Diabetes Diagnosis Guidelines Could Need Reassessment After Retinopathy Study

February 29. 2008 (EurekAlert) - A study into how diabetes mellitus is connected to the common diabetic complication retinopathy suggests that the guidelines for diagnosing diabetes could need reassessment. These are the conclusions of authors of an Article in this week's edition of The Lancet.

Diabetes will affect an estimated 380 million people by 2025. Both WHO and the American Diabetes Association diagnose diabetes on the basis of a person's blood "fasting plasma glucose" (FPG) concentration -- those with a value of 7.0 mmol/L or higher are classed as diabetic. Retinopathy -- small blood vessel damage to the eye -- is a common complication of diabetes, which can lead to blindness. Three major studies in the 1990s have shown that retinopathy signs were rare below an FPG threshold of 7.0 mmol/L, but that their prevalence increased substantially above it. However one of these studies assessed retinopathy from a direct clinical ophthalmoscopic examination, and the other two from one retinal photograph. None used the current gold standard in clinical trials -- multiple field retinal photographs. Furthermore, early reports from the Diabetes Prevention Programme suggest many people have signs of retinopathy below an FPG of 7.0 mmol/L.

Professor Tien Wong, Centre for Eye Research Australia, University of Melbourne, VIC, Australia, and colleagues looked at three further studies in which multiple field retinal photographs were used to define retinopathy -- the Blue Mountains Eye Study (BMES, Australia, 3162 people); the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab, Australia, 2182 people); and the Multi-Ethnic Study of Atherosclerosis (MESA, USA, 6079 people).

The researchers found that the overall prevalence of retinopathy in the general population ranged from 9.6% to 15.8%. They found no evidence of a clear and consistent FPG threshold for the presence or incidence of retinopathy across the different populations. In fact, more than 60% of retinopathy cases were missed by the widely used diabetes cutoff of 7.0mmol/L -- since these patients had FPG levels below this limit.

The authors say: "We found no uniform FPG glycaemic threshold for retinopathy across different populations and poor performance of current FPG cutoffs in separating individuals with and without retinopathy, largely due to the much higher prevalence of retinopathy at low FPG concentrations than previous studies reported."

They conclude: "These findings could help unify the understanding of the risk of complications from diabetes, suggesting that both macrovascular (large vessel) and microvascular (small vessel) complications do not seem to respect a glycaemic threshold. These findings further question the validity of the current WHO and American Diabetes Association approach of using retinopathy to derive FPG thresholds for diagnosing diabetes, and point to the need to revisit current diagnostic criteria for diabetes."

In an accompanying Comment, Drs Quresh Mohamed and Alison Evans, Cheltenham General Hospital, Cheltenham, UK, say that while current diagnostic criteria may be limited "the current cut-offs do seem to distinguish a group with substantially higher risk of harm." They also call for larger prospective studies into the relationship between impaired glycaemic control and various complications.

They conclude: "We perhaps should focus less on a single universal cut-off and instead target resources on the basis of standardised evidence-based individual risk scores in which measures of glycaemia are combined with other risk factors. But what would we tell our patients when they asked if they had diabetes" We are probably best sticking with what we know until a better alternative diagnostic tool becomes available."

Posted by dlife at 04:41 PM | Comments (1)

ADVANCE Diabetes Trial Results Confirm No Evidence of Safety Risk

Findings from largest-ever clinical trial of diabetes treatments show no evidence that intensive treatment to lower blood glucose is associated with increased mortality

February 28, 2008 (EurekAlert) - Data from the ADVANCE Study, involving 11,140 high-risk patients with type 2 diabetes, provides no evidence of an increased risk of death among those patients receiving aggressive treatment to lower blood glucose.

This contrasts findings from the 10,251 patient ACCORD trial which halted the intensive glucose control arm of the study 18 months early because a data review revealed that patients who received intensive treatment to lower blood glucose are at higher risk for death. While the trial will continue, patients will be transitioned from the intensive treatment arm (targeting A1c levels of <6.0 %) to the less intensive, standard treatment arm (targeting A1c levels of 7.0 to 7.9%).

“Unlike what we saw in ACCORD, a rigorous review of ADVANCE data by the Data and Safety Monitoring Committee shows that the treatment strategy of intensively lowering blood sugar does not pose greater risk to our patients with type 2 diabetes”, says Canadian lead investigator and member of ADVANCE Management Committee Dr. Pavel Hamet, professor of Medicine, Canada Research Chair of Predictive Genomics at Université de Montréal and Chief, Gene Medicine Services at Centre Hospitalier de l’Université de Montréal. “ADVANCE is a landmark study and will continue as planned to completion. The results will provide crucial information to help us better reduce the significant health risks associated with type 2 diabetes.”

Type 2 diabetes increases the risk of many complications, especially cardiovascular disease, which is the leading cause of death in people with diabetes. Both the ADVANCE and ACCORD studies examined the effects of intensive blood glucose and blood pressure control on the risk of cardiovascular events such as heart attack, stroke, or death from cardiovascular disease in patients with type 2 diabetes. A successful reduction in overall and cardiovascular mortality in the intensive blood pressure arm has been reported from the ADVANCE trial and published in The Lancet in September 2007.

In ADVANCE and ACCORD, the intensive treatment arm targeted blood glucose levels below those recommended in current treatment guidelines because previous studies suggest that reducing blood sugar to levels to those found in non-diabetic adults may reduce the rate of cardiovascular disease in patients with diabetes.

In the ADVANCE trial, which involves 20 countries worldwide including Canada, the intensive blood glucose lowering program aimed to reduce levels of hemoglobin A1c (a marker of long term blood glucose control) to ≤6.5%. Treatment included a sulfonylurea drug, gliclazide modified release, for all patients, and a number of other agents for those patients unable to reach target blood glucose levels. The ADVANCE trial was started in 2001 and patients were followed for an average of five years.

Because the A1c targets in ACCORD and ADVANCE are similar, and the intensive blood glucose control arm of ACCORD was stopped early, the ADVANCE mortality data was reviewed by the Data and Safety Monitoring Committee to determine if there was a similar excess risk of mortality. This committee advised that data did not provide any confirmation of the adverse mortality trend reported from ACCORD.

“Final patient visits have been completed and the ADVANCE study data base is close to finalization. We expect to have definitive results soon,” said Study Director, Dr. Anushka Patel, from The George Institute in Sydney, Australia. “At this stage, the Data Monitoring and Safety Committee have reviewed results that are more than 99% complete, so we are confident that the interim findings are a reliable guide to the final results.”

Final data from the ADVANCE trial is expected to be promising in terms of risk minimization but multiple analyses are required before conclusions can be drawn regarding the effects of intensive glucose control on patient outcomes. Additional data will be available specifically from ADVANCE, and Dr. Hamet’s team, in collaboration with Prognomix in Montréal, is performing genomic studies of the risk of complications of diabetes in this unique worldwide patient cohort.

The ADVANCE trial was conducted by an independent collaborative group of medical researchers with support from the National Health & Medical Research Council of Australia and the Institut de Recherche Internationales Servier. The results of the blood pressure control arm of ADVANCE were presented at the annual meeting of the European Society of Cardiology in Vienna, Austria in September 2007. Final results of the glucose control arm of the ADVANCE trial will be released earlier than expected, by the middle of 2008.

Posted by dlife at 04:38 PM | Comments (0)

Researchers Look for Explanation Behind High Incidence of Diabetes Among Asian Indians

February 29, 2008 (Newswise) - The incidence of type 2 diabetes is rising, especially in urbanized parts of the world where sedentary lifestyles and obesity abound. In addition to weight and inactivity, race puts some people at increased risk for developing type 2 diabetes. The incidence of diabetes is rapidly increasing globally, and Asian Indians have the highest prevalence. An estimated 32 million Asian Indians have been diagnosed with this condition, and some experts expect this number to double over the next 30 years. In a study published in the March issue of Diabetes, Mayo researchers examined whether Asian Indians have observable differences in the way their cells convert nutrient fuel to available energy and whether these differences may increase the risk for diabetes.

“We know that Asian Indians are highly susceptible to this condition, and they often acquire the disease at an earlier age and at lower body mass index than people of European origin,” explains Mayo endocrinologist K. Sreekumaran Nair, M.D., Ph.D., the study’s lead researcher. “The question we asked is whether any metabolic differences between Asian Indians and Americans of Northern European origin can explain the higher incidence of diabetes in Indians.”

Once known as adult-onset or non-insulin-dependent diabetes, type 2 diabetes is a chronic condition that affects the way the body utilizes sugar (glucose). People with type 2 diabetes don’t produce enough insulin -- a hormone that regulates the absorption of sugar into cells -- and their cells resist the effects of insulin (insulin-resistant). While death rates due to heart attack, stroke and even cancer are decreasing, deaths related to diabetes are increasing. Type 2 diabetes is the leading cause of cardiovascular deaths, kidney failure, blindness, sexual dysfunction and many other chronic complications.

Mayo researchers studied 13 diabetic Indians, 13 nondiabetic Indians, and 13 nondiabetic northeast Americans of European descent who were matched for gender, age and body mass to Indian study participants. Study participants were fed the same diet and underwent tests for insulin resistance and muscle biopsy to see whether differences occurred at the cellular level among the different study subject groups.

The study yielded a number of interesting findings. Researchers observed that the Indian subjects, irrespective of their diabetic status, had a greater degree of insulin resistance than the American subjects of Northern European origin, even though the study subjects were not obese, a condition commonly associated with insulin resistance. Earlier research has established that people with insulin resistance typically have poorly functioning muscle mitochondria. Mitochondria are the part of cells responsible for converting energy from nutrients to ATP (adenosine triphosphate), the chemical form of cellular energy that the body uses for almost all functions.

“Our study showed that the Indian diabetic and nondiabetic subjects with insulin resistance actually had mitochondrial function that was higher than those observed in the Northern European American subjects,” says Dr. Nair.

Dr. Nair hypothesizes that key to understanding this difference may lie in an examination of how populations adapt as they become more urbanized. Urban societies typically move away from lifestyles that involve a higher level of physical activity and diets dominated by low-calorie foods.

“The higher capacity to produce ATP that the Indian subjects displayed may have been an adaptive advantage for the generations that preceded them, when energy content of their diet was lower. But today, this trait may be a disadvantage given the higher energy content of their current diets,” explains Dr. Nair.

Dr. Nair and his team are hopeful that the information gained from this study will have a substantial impact on understanding the cause of the global epidemic in diabetes.

“Our findings have potential to help determine the energy requirements of different populations and what role this plays in the onset of diabetes” says Dr. Nair.

Posted by dlife at 09:34 AM | Comments (0)

Race, Insurance Status Affect Access to Transplantation and Kidney Disease Treatment

February 28, 2008 (Newswise) — Universal access to health care might help to overcome racial and ethnic barriers to treatment for kidney disease, suggest two studies in the March 2008 issue of Clinical Journal of the American Society of Nephrology.

The results should be seen as "yet another wake-up call as to how we as a medical community need to lead the health agenda for the nation, including the reduction and/or elimination of health disparities," according to an editorial by Dr. Keith Norris of Charles Drew University and Dr. Allen Nissenson of the David Geffen School of Medicine at UCLA.

In one of the two new studies, Dr. Douglas Keith of McGill University, Montreal, and colleagues analyzed data on nearly 76,000 U.S. patients wait-listed for kidney transplantation between 2001 and 2004. The goal was to identify factors affecting time on dialysis before being placed on the waiting list—the less time a patient spends on dialysis, the better the results of transplantation.

During the four-year study period, there was a significant increase in the rate of "pre-emptive listing"—that is, being placed on the transplant waiting list before starting dialysis. However, the median time spent on dialysis before wait-listing was essentially unchanged.

The rate of pre-emptive listing was lower, and time spent on dialysis was longer, for minority patients and for patients on Medicare (compared to those on private insurance).

Less-educated patients and those whose kidney disease was caused by high blood pressure also had a reduced rate of pre-emptive wait-listing and a longer time on dialysis. On average, a minority patient who was on Medicare and had less than a high school education spent 20 times longer on dialysis before being wait-listed, compared to a white patient with private insurance and at least a high school education.

The impact of insurance was greatly reduced after age 65. At that age, Medicare patients no longer have to go through a mandatory waiting period before being eligible for kidney transplantation. However, the disparities for racial and ethnic minorities and for less-educated patients persisted after age 65.

"The most important issue for timely access to the waiting list is insurance or the lack of it," Dr. Keith comments. "Our study suggests that a universal system of insurance coverage would improve access for those most disadvantaged by the current insurance system." The study is limited in that it includes only patients who actually made it to the waiting list.

In the second study, Dr. Sam W. Gao of Naval Medical Center Portsmouth (Virginia) and colleagues analyzed the quality of care for more than 8,000 patients with moderate to advanced chronic kidney disease (CKD) treated in the Department of Defense (DOD) medical system. Their goal was to determine whether universal access to health services in the DOD system avoids racial disparities in CKD care.

The results suggested that the care provided to black patients with CKD in the DOD system was very similar to that provided to white patients. In some cases, measures of kidney care were higher for black patients. The one significant difference was lower monitoring of cholesterol levels among black patients.

"We were able to show that blacks and whites received similar care, unlike some other aspects of medicine in the United States where blacks receive less care than whites," Dr. Gao comments. "This may be due to universal access to care provided to all DOD beneficiaries." The study is limited in its ability to show a cause-and-affect relationship, and by the fact that it included only DOD beneficiaries.

In their editorial, Drs. Norris and Nissenson call on the nephrology community to "take the opportunity as health leaders to ensure uniform health care to all citizens and move closer to eliminating the tragedy of health inequities, and the unacceptable morbidity and mortality associated with CKD." They note that the American Society of Nephrology (ASN), National Kidney Foundation (NKF), Renal Physicians Association (RPA), and American Society of Pediatric Nephrology (ASPN) are collaborating on a legislative agenda to improve care for patients with kidney disease, focusing on appropriate funding for CKD care. In conjunction with World Kidney Day on March 13, 2008, members from ASN and NKF will visit with congressional leaders on Capitol Hill to discuss the importance of improving care for patients with kidney disease through greater access, more research, and increased education.

The ASN is a not-for-profit organization of 10,500 physicians and scientists dedicated to the study of nephrology and committed to providing a forum for the promulgation of information regarding the latest research and clinical findings on kidney diseases.

Posted by dlife at 04:54 PM | Comments (0)

Overweight Hispanic Children Shown To Have Vascular Inflammation

February 27, 2008 (Joslin Diabetes Center) — Overweight Hispanic children with normal blood glucose (sugar) levels showed elevated markers for blood vessel inflammation that may predispose them to developing both type 2 diabetes and cardiovascular disease, says a new study led by researchers from the Joslin Diabetes Center.

The study, published in the March issue of Diabetes Care, is the first to focus on Hispanic children, already known to be at high risk for developing type 2 diabetes as a result of both genetic and lifestyle factors.

“Our findings suggest that these children are not only at risk for type 2 diabetes, but also for cardiovascular disease,” said Dr. A. Enrique Caballero, lead investigator.

The study looked at 38 Hispanic children and adolescents, ages 10 through 18. Twenty-one were obese but with normal blood glucose levels, so they had not yet developed diabetes. The rest were considered lean. As a group, the obese subjects had significantly higher percentages of body fat than the lean group and were already showing signs of insulin resistance, meaning the insulin that their bodies produce is not working well and as a consequence their pancreases were being forced to work harder to produce more insulin to maintain normal blood sugar levels.

Overall, the obese group exhibited increased blood markers for subclinical or asymptomatic inflammation of the inner layer of blood vessels. “They are already exhibiting problems with circulation,” said Caballero, Director of the Latino Diabetes Initiative, Clinical Investigator, Staff Endocrinologist and Director, Medical Affairs, Professional Education at Joslin Diabetes Center, as well as an Assistant Professor of Medicine at Harvard Medical School. “There is an inflammatory process going on in the vessels.”

Such problems suggest these children may be at increased risk of developing cardiovascular problems at a young age, he said.

Subclinical vascular inflammation is a key element in the development of cardiovascular disease and is closely associated with insulin resistance. It also predicts the development of type 2 diabetes.

Earlier studies in overweight or obese children and adolescents showed similar vascular abnormalities, but were conducted primarily in non-Hispanic children.

Caballero wanted to study Hispanic children because they had not previously been studied and because they are a high-risk population for type 2 diabetes.

“We have found that overweight Hispanic children and adolescents have elevated markers of endothelial dysfunction and vascular inflammation closely related to excess body fat and increased insulin resistance,” the paper concluded. “This. . . may increase their risk of developing type 2 diabetes and cardiovascular disease, further emphasizing the need for obesity prevention strategies.”

Caballero said such strategies must be culturally appropriate.

“Even if these abnormalities may not be that different than those in Caucasian children, the strategies to prevent heart disease and diabetes need to be culturally oriented,’’ he said. “They need to be tailored to the population.”

Caballero stressed that the findings do not mean that such children will definitely develop type 2 diabetes or cardiovascular problems, but said the idea is to step in early to make sure they don’t.

“The problem is serious enough to warrant attention and a prevention strategy,” he said.

The research was funded by a grant from Sanofi Aventis and a National Institutes of Health grant for general clinical research at Beth Israel Deaconess Medical Center.

In addition to Dr. Caballero, other researchers participating in the study included: Dr. Ludivina Robles-Osorio, Valeria Montagnani, RN, Dr. Geetha Soodini, Dr. Sriurai Porramatikul, Dr. Osama Hamdy and Dr. Edward S. Horton from the Joslin and Kelb Bousquet-Santos and Dr. Antonio C.L. Nobrega from Fluminense Federal University in Brazil.

Posted by dlife at 11:20 AM | Comments (0)

Joslin Diabetes Center and The Barton Center for Diabetes Education Reach Agreement for Barton to Manage Camp Joslin

February 25, 2008 (Joslin) – The Barton Center for Diabetes Education, Inc. and the Joslin Diabetes Center announced today that The Barton Center will manage and operate Camp Joslin in Charlton, Mass.
Under the agreement, The Barton Center assumes responsibility for all management and operations of Camp Joslin. Joslin retains ownership of Camp Joslin. Camp Joslin programs include a summer resident camp serving about 350 boys with insulin-dependent diabetes each year, co-ed wilderness programs and other co-ed programs in the winter and spring.

“Since its founding, Camp Joslin has been a life-saving resource for boys with insulin-dependent diabetes and their families,” said Paul O’Brien, Senior Vice President, Joslin Diabetes Center. “We believe The Barton Center, which has an excellent reputation for its leadership in year-round camping and education programs, will do a fantastic job extending the reach of Camp Joslin to more kids and families with diabetes.”

The Barton Center’s year-round camp, retreat and conference center serves 1,500 children and their families annually. Barton’s programs include a summer resident camp for girls, co-ed day camps, co-ed adventure camps, family camp and numerous co-ed and family programs in the fall, winter and spring.

Barton Executive Director Jonas B. Goldenberg said the agreement provides an opportunity for both camps to grow and to have an even greater impact on children with diabetes and their families.

“We are delighted with the opportunity to manage Camp Joslin, which perfectly complements our mission,” Goldenberg said. “By helping us reach more children, this agreement further fulfills Barton’s mission of improving the lives of children with insulin-dependent diabetes by providing a fun environment that inspires, empowers and motivates children with diabetes, while helping their families to thrive.”

Goldenberg said he expects that managing the two camps will create opportunities to enhance future programming and to attract more families and children who are living with diabetes.

The two camps, which will remain at their current locations, have much in common and have experience working together. They are located fewer than five miles away from each other, and both camps have a long heritage of camping and outdoor activities, combined with diabetes education and support for children with diabetes. In addition, they have jointly operated a highly successful winter camp program at the Barton location for the past two years.

Dr. Elliott P. Joslin, founder of Joslin Diabetes Center, who was born in Oxford, Mass., helped found both camps and served as medical director at both camps in the early days. Both camps consistently meet or exceed the strict standards of quality set forth by the American Camp Association and other licensing and accreditation organizations.
Anyone interested in more information or in registering for either camp for Summer 2008 can contact The Barton Center at 508-987-2056.

Posted by dlife at 05:29 PM | Comments (0)

Eucreas®, a Single-Tablet Combination of Galvus® and Metformin, Set for Launch in First EU Countries as New Treatment for Type 2 Diabetes

February 25, 2008 (Press Release) - European health authorities have approved Eucreas®, an oral tablet combining Galvus® (vildagliptin) and metformin, as a new treatment for patients with type 2 diabetes. Eucreas is the first single-tablet combination of a member of the new DPP-4 inhibitor class with metformin to be approved in the European Union.

The approval comes after Novartis proposed changes to the EU label recommending that liver monitoring should be conducted at the start of treatment, every three months for the first year, and periodically thereafter. The Eucreas approval closely follows European approval of the updated label for Galvus announced earlier this month.

The decision applies in all 27 countries of the EU as well as in Norway and Iceland, and both medicines will be available in the first European countries within the next few weeks.

Studies show that more than half of patients currently taking medication to manage their type 2 diabetes are still not reaching blood glucose goals[1]. Combination therapy usually becomes necessary due to progressive worsening of blood sugar control during the natural course of the disease[2].

In clinical studies, patients inadequately controlled on metformin, one of the most prescribed oral therapies for type 2 diabetes, were four times more likely to achieve blood sugar control by adding Galvus to their treatment compared to those who added a placebo (or sugar pill)[3]. Furthermore, Galvus when administered with metformin resulted in additional blood sugar reductions of 1.1% as measured by HbA1c[4], the gold standard measure of blood sugar control[5].

"The approval of Eucreas marks an important step forward in the management of type 2 diabetes, as it is the first single-tablet combination of a DPP-4 inhibitor with metformin for patients in Europe," said James Shannon, MD, Chief Medical Officer at Novartis Pharma AG. "The complementary actions of Galvus and metformin, which are the medicines combined in Eucreas, help to bring blood sugar levels under control without the side effects commonly associated with many widely-used type 2 diabetes medicines."

In clinical trials, the addition of Galvus to metformin provided robust blood sugar control without weight gain and with fewer cases of hypoglycemia (i.e. dangerously low blood sugar)[4], side effects associated with other therapies for type 2 diabetes such as sulfonylureas or thiazolidinediones.

Eucreas has been approved for use in type 2 diabetes patients who are inadequately controlled with metformin alone, or are being treated with Galvus and metformin as separate tablets. Eucreas is recommended for use twice-daily at a dose of either 50 mg vildagliptin/850 mg metformin or 50 mg vildagliptin/1000 mg metformin.

Eucreas combines two agents that work together to target both a dysfunction in the pancreatic islets and insulin resistance, two of the main factors contributing to type 2 diabetes. Galvus works through a novel mechanism of action that targets islet dysfunction and restores the body's natural ability to increase insulin and decrease glucagon - the two main hormones controlling blood sugar levels. Metformin works mainly by decreasing the production of sugar by the liver and increasing insulin sensitivity.

Type 2 diabetes is a progressive disease in which control of blood sugar deteriorates over time. If left untreated or not kept under control, it can lead to heart and kidney disease, blindness, and vascular or neurological problems[6].

References
[1] Saydah S, et al. Poor Control of Risk Factors for Vascular Disease Among Adults With Previously Diagnosed Diabetes. JAMA 2004: 291(3): 335-342.
[2] Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA 281:2005-2012, 1999.
[3] Dejager S, et al. Achievement of Glycemic Targets with Vildagliptin. Presented at EASD 17-21 September 2007. (Abstract A-07-899).
[4] Bosi E, et al. Effects of Vildagliptin on Glucose Control Over 24 Weeks in Patients With Type 2 Diabetes Inadequately Controlled With Metformin. Diabetes Care. 2007; 30:890-895.
[5] American Diabetes Association. Standards of Medical Care in Diabetes - 2006. http://care.diabetesjournals.org/cgi/content/full/29/suppl_1/s4
[6] International Diabetes Federation Diabetes Atlas. Third edition 2006: http://www.eatlas.idf.org/

Posted by dlife at 10:47 AM | Comments (0)

Highly Involved Patients Don't Always See Better Health Outcomes

February 22, 2008 (Newswise) — Patients who prefer to be highly involved in their treatment don't necessarily have better luck managing chronic health conditions, a new study suggests.

A research team based at the Veterans Affairs (VA) Iowa City Health Care System and the University of Iowa surveyed 189 veterans with high blood pressure to determine the patients' preferences for involvement in their health care. They discovered those who wanted an active role in their treatment had higher blood pressure and cholesterol over a 12-month span than those who wanted a less active role.

The study, published this week in the Annals of Behavioral Medicine, was led by Austin Baldwin, a post-doctoral fellow in the Center for Research in the Implementation of Innovative Strategies in Practice (CRIISP) at the VA Iowa City Health Care System and an adjunct assistant professor of psychology in the UI College of Liberal Arts and Sciences.

"The intuitive assumption is that the more involved people are with their health, the better they'll be at managing chronic conditions. We found evidence to the contrary," Baldwin said. "Those who preferred a more 'patient-centered' or active role actually had higher blood pressure and lipid levels. Those who preferred a 'provider-centered' approach, in which the doctor is more authoritative, did better at managing their blood pressure and lipid levels."

Patients who preferred the most active role averaged a blood pressure of 141 over 79 and a low-density lipoprotein (LDL) cholesterol level of 112, while those who preferred the least active role averaged a blood pressure of 137 over 72 and an LDL of 92. Doctors tell most patients with high blood pressure to aim for a blood pressure less than 140 over 90 and keep LDL cholesterol under 130.

The average participant was 65.8 years old, and 97 percent were men. Participants were recruited from the Iowa City and Minneapolis VA health care systems and four affiliated community-based outpatient clinics as part of a larger hypertension trial. The data were collected in 2004.

The research team offered a couple potential explanations for the results.

One possibility is that patients who wanted an active role were dissatisfied with the relatively passive treatment of taking medication to control their conditions, and therefore may not have followed doctors' orders as well.

"They were presumably provided advice and guidance about modifying their lifestyle, but all of these patients were on hypertension medication, and many were on lipid-lowering medications," Baldwin said. "For those who want more control over their treatment, a relatively passive treatment like taking medication may not be a good match."

One aspect of the study gave traction to this explanation. Some patients were diabetic. While those who preferred an active role did worse at managing blood pressure and cholesterol, they did slightly better at managing blood sugar (although the effect on managing blood sugar was not statistically significant). Researchers believe that's because managing blood sugar is a more hands-on treatment involving blood sugar tests, diet regulation and sometimes medication.

Another potential explanation is that the patients' role preferences didn't match their doctors' role preferences. While this study did not assess providers' preferences, previous research suggests that a mismatch between patients' and providers' role preferences impacts adherence to treatment recommendations. (See related UI study at http://www.news-releases.uiowa.edu/2007/August/081007patient-centered.html.)

Baldwin said the research is important because if health professionals can assess patients' role preferences, they could potentially tailor treatment plans to give patients the best chance for a successful outcome. For example, patients with high blood pressure who want an active role could do better making more aggressive lifestyle changes and tracking their progress with a home blood pressure monitor, he said.

"The upshot of this research is that there isn't a one-size-fits-all approach. It's nice to think if we give everyone Treatment X, they're all going to do well," Baldwin said. "But individual differences and preferences are important, and the value of studying this is to understand how these preferences can influence treatment adherence and ultimately influence people's health."

Co-authors of the paper were Jamie Cvengros, a UI graduate student in psychology and a clinical intern at Rush Medical Center in Chicago; Alan Christensen, professor and chair of the UI Department of Psychology and an investigator at the VA Iowa City Health Care System's CRIISP; Areef Ishani, an investigator at the VA system in Minneapolis; and Peter Kaboli, associate professor of internal medicine in the UI Roy J. and Lucille A. Carver College of Medicine and an investigator at the VA Iowa City Health Care System's CRIISP.

The VA Health Services Research and Development Service provided support for the study.

Posted by dlife at 10:41 AM | Comments (1)

Standard Test for Blood Sugar Control Not Accurate in Diabetic Dialysis Patients

February 21, 2008 (EurekAlert) - The standard test for measuring blood sugar control in people with diabetes is not accurate in those on kidney hemodialysis, according to new research at Wake Forest University Baptist Medical Center.

Wake Forest investigators reported in Kidney International that the hemoglobin A1c test (HbA1c) underestimates true glucose control in hemodialysis patients and could give false comfort to patients and physicians. Hemodialysis, in which blood is passed through an artificial kidney machine for cleansing, is used in cases of kidney failure.

“These results suggest that the nearly 200,000 diabetic hemodialysis patients in the United States who use this test may not be receiving optimal care for their blood sugar,” said Barry I. Freedman, M.D., senior author and a professor of internal medicine and nephrology.

Diabetic dialysis patients who believe their blood sugars are in the ideal range may still have unacceptably high blood sugars. “This was a surprise to the nephrology community,” said Freedman. “The test we’ve all come to accept as ‘the gold standard’ has proven to be inaccurate in this patient population.”

HbA1c measures the percentage of hemoglobin (a protein in red blood cells) that has reacted with glucose. This measure, also known as glycosylated hemoglobin, reflects blood sugar control over the previous 30-120 days.

This study evaluated 307 patients with diabetes – 258 with end-stage kidney disease on hemodialysis and 49 who did not have kidney failure. The researchers compared the standard HbA1c test with a newer test (glycated albumin, or GA) that measures the amount of blood sugar that has reacted with albumin, a protein in the plasma. The GA test reflects blood sugar control over the previous three to four weeks. Blood samples were also analyzed to determine recent blood sugar levels.

Compared to those without kidney failure, diabetic patients on hemodialysis had higher blood sugars and GA levels, despite paradoxically lower HbA1c results. The relationship between GA and HbA1c differed between diabetic dialysis patients and those without kidney disease, demonstrating that the HbA1c did not accurately reflect blood sugar control in those on hemodialysis.

Researchers believe the major reason for the discrepancy is that HbA1c depends on red blood cell survival and these cells don’t live as long in hemodialysis patients. Most dialysis patients have anemia requiring treatment with medications that stimulate red blood cell production (erythropoietin).

The current study confirmed a report in Japanese patients and is the first to demonstrate the inaccuracy of the HbA1c in black and white dialysis patients. The Wake Forest researchers will soon determine whether these concerns also apply to patients on peritoneal dialysis and to people with kidney disease not yet on dialysis.

Controlling blood sugar is important because high levels are risk factors for developing hardening of the arteries (atherosclerosis) and lead to higher rates of kidney disease, heart attack, stroke, nerve damage and blindness. People with diabetes who undergo hemodialysis are at especially high risk. About one out of four diabetic dialysis patients (23 percent) in the U.S. will die from cardiovascular and infection complications during their first year on dialysis, and only 31 percent survive five years.

“Control of blood sugar improves outcomes of diabetic patients, so accurate assessment is critical,” said Freedman. “This study supports the GA test as a more accurate measure of long-term blood sugar control among diabetic patients who are on hemodialysis.”

The GA test is not currently available in the United States. Freedman said that until it is available, doctors and patients should be aware that the HbA1c underestimates glucose control and is affected by both erythropoietin administration and the hemoglobin concentration.

Posted by dlife at 12:00 PM | Comments (0)

Novel Link Between Excessive Nutrient Levels and Insulin Resistance

February 21, 2008 (EurekAlert) — For quite some time now, scientists suspected the so-called hexosamine pathway — a small side business of the main sugar processing enterprise inside a cell — to be involved in the development of insulin resistance. But they could never quite put their finger on the underlying mechanism.

Now, researchers at the Salk Institute for Biological Studies have uncovered the long-missing molecular link: the enzyme OGT (short for O-linked ß-N-acetylglucosamine transferase), the last in a line of enzymes that shuttle sugars through the hexosamine pathway.

Their study revealed that OGT slams the brake on insulin signaling soon after insulin fires up the machinery that pulls glucose from the blood stream and squirrels it away inside liver or stashes the surplus energy in fat pads.

“For the first time we have a real understanding of how the insulin signaling system is turned on and off,” says Howard Hughes Medical Investigator Ronald M. Evans, Ph.D., a professor in the Salk Institute’s Gene Expression Laboratory, who led the study that appears in the Feb. 21 issue of Nature.

He hopes that “this could lead to a new class of insulin-sensitizing drugs that loosen the brake and let insulin work a little bit longer.”

When insulin binds its receptor on the cell surface it sets off a cascade of intracellular signals resulting in the production of PIP3, a specialized lipid molecule that masterminds a whole army of molecules that work together to synthesize and store carbohydrates, lipids and proteins. “But turning on a physiological process is only half the story,” explains Evans. “You also need instructions that tell the cell to get off the accelerator and put on the brake.”

Postdoctoral researcher and first author Xiaoyong Yang, Ph.D., discovered that PIP3 oversees both. His experiments revealed that within minutes activation of the insulin signaling network coaxes OGT out of the nucleus and into the cytoplasm. It travels to the plasma membrane and hooks up with PIP3.

“It uses a novel PIP3 binding domain to interact with the same lipid that just turned on the system,” describes Xiaoyong. “After OGT is recruited to the plasma membrane it starts turning off the system.”

It accomplishes this task by tagging key members of the insulin signaling network with sugar molecules, specifically O-linked ß-N-acetylglucosamine or O-GlcNAc, which are produced by the hexosamine pathway.

Since the amount of O-GlcNAc is directly tied to availability of glucose, lipids and other nutrients in the bloodstream, the researchers believe that the hexosamine pathway acts as fuel gauge, protecting the body’s cells against the toxic effects of too much glucose and other high-energy molecules.

Excessive quantities of nutrients — the result of a lifestyle where food is plentiful and exercise is optional — drive O-GlcNAc levels up, which in turn dampen the insulin response, paving the way for a relentless progression of insulin resistance.

Though it may not be as simple as that, when Xiaoyong put OGT into overdrive in the livers of mice, the animals developed insulin resistance and abnormal blood lipid levels, emphasizing the importance of the hexosamine pathway for the development of insulin resistance, the first step towards full-blown type 2 diabetes.

Most people with insulin resistance go on to develop type 2 diabetes within 10 years, unless they lose 5 to 7 percent of their body weight—approximately 10 to 15 pounds for someone who weighs 200 pounds—by making modest changes in their diet and level of physical activity. But making permanent lifestyle changes is difficult and studies predict that one in three Americans born in the year 2000 will develop diabetes in their life time. A similar fate awaits most developed nations.

Posted by dlife at 10:45 AM | Comments (0)

Obesity Increases Cancer Risk, Analysis Of Hundreds Of Studies Shows

February 18, 2008 (Science Daily) - Researchers from the University of Manchester, Christie Hospital and University of Bern in Switzerland have today published findings in the Lancet medical journal which further support the link between obesity and risk of developing cancer.

Following on from findings reported by the World Cancer Research fund last year, the study reveals that risk is increased not only in common cancers such as breast, bowel and kidney, but also in less common cancers such as blood cancers (myeloma and leukaemia) and melanoma (a form of skin cancer).

Dr Andrew Renehan and colleagues from the University of Manchester and Christie Hospital, did a meta-analysis (a combined analysis of 221 previous studies), looking at over 250,000 cases of cancer, to determine the risk of cancer associated with a 5kg/m2 increase in body mass index (BMI).

The researchers found in men, a 5kg/m2 increase in BMI raised the risk of oesophageal adenocarcinoma by 52%, thyroid cancer by 33%, and colon and kidney cancers each by 24%.

In women, a BMI increase of 5kg/m2 increased the risk of endometrial (59%), gallbladder (59%), oesophageal adenocarcinoma (51%) and kidney (34%) cancers.

They also noted weaker, but significant, positive associations between increased BMI and rectal cancer and malignant melanoma in men; postmenopausal breast, pancreatic, thyroid, and colon cancers in women; and leukaemia, multiple myeloma, and non-Hodgkin's lymphoma in both sexes. They found associations were stronger in men than in women for colon cancer - 24% in men compared with 9% in women.

The study looked at cancer data from all over the world, and while the results for North America, Europe, Australia and the Asia-Pacific region were broadly similar, there was a stronger link between increased BMI and both premenopausal and post menopausal breast cancers in Asia-Pacific populations.

The senior author on the study, Dr Andrew Renehan, said: "This was a hugely comprehensive piece of research looking at 221 different studies in 20 types of cancer. For some cancer types, associations differ between sexes and populations of different ethnic origins and this should inform the exploration of biological mechanisms that link obesity with cancer."

He added: "Over the past five years, there was been increasing proof that obesity is linked with cancer risk, but despite this, we do not know whether weight reduction in people protects them against cancer. The findings of this study are important to address these issues and explore ways to prevent cancers in the future."

In an accompanying comment, Dr Susanna Larsson and Dr Alicja Wolk, Division of Nutritional Epidemiology, National Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, say: "The number of deaths per year attributable to obesity is about 30000 in the UK and ten times that in the USA, where obesity has been estimated to have overtaken smoking in 2005 as the main preventable cause of illness and premature death."

They conclude: "Efforts will be needed to increase education on diet and physical activity, train health professionals, restrict advertisements of high-calorie and low-nutrient foods, limit access to unhealthy foods in schools and workplaces, levy taxes on sugary drinks and other foods high in calories, fat, or sugar, lower the prices of health foods, and promote physical activity in schools and workplaces. National cancer plans should include all these factors to reduce obesity, and thus decrease cancer incidence and increase survival."

Adapted from materials provided by University of Manchester.

Posted by dlife at 01:53 PM | Comments (1)

Stress Hormone Impacts Memory, Learning in Diabetic Rodents

February 17, 2008 (EurekAlert) - Diabetes is known to impair the cognitive health of people, but now scientists have identified one potential mechanism underlying these learning and memory problems. A new National Institutes of Health (NIH) study in diabetic rodents finds that increased levels of a stress hormone produced by the adrenal gland disrupt the healthy functioning of the hippocampus, the region of the brain responsible for learning and short-term memory. Moreover, when levels of the adrenal glucocorticoid hormone corticosterone (also known as cortisol in humans) are returned to normal, the hippocampus recovers its ability to build new cells and regains the “plasticity” needed to compensate for injury and disease and adjust to change.

The study appears in the Feb. 17, 2008, issue of Nature Neuroscience and was conducted by the National Institute on Aging (NIA), part of the NIH. NIA’s Mark Mattson, Ph.D., and colleagues in the Institute’s Intramural Research Program performed the study with Alexis M. Stranahan, a graduate student at Princeton University in New Jersey.

“This research in animal models is intriguing, suggesting the possibility of novel approaches in preventing and treating cognitive impairment by maintaining normal levels of glucocorticoid,” said Richard J. Hodes, M.D., NIA director. “Further study will provide a better understanding of the often complex interplay between the nervous system, hormones and cognitive health.”

Cortisol production is controlled by the hypothalamic-pituitary axis (HPA), a hormone-producing system involving the hypothalamus and pituitary gland in the brain and the adrenal gland located near the kidney. People with poorly controlled diabetes often have an overactive HPA axis and excessive cortisol produced by the adrenal gland. To study the interaction between elevated stress hormones and the hippocampal function, researchers tested the cognitive abilities and examined the brain tissue in animal models of rats with Type 1 diabetes (insulin deficient) and mice with Type 2 diabetes (insulin resistant).

Researchers found that diabetic animals in both models exhibited learning and memory deficits when cortisol levels were elevated due to impaired plasticity and declines in new cell growth. Returning the levels to normal, however, reversed the negative impact on the hippocampus and restored learning and memory.

“This advance in our understanding of the physiological changes caused by excessive production of cortisol may eventually play a role in preventing and treating cognitive decline in diabetes,” said Mattson, who heads the NIA’s Laboratory of Neurosciences. He and Stranahan explained these findings may also help explain the connection between stress-related mood disorders and diabetes found in human population studies.

Posted by dlife at 09:15 AM | Comments (0)

Research Findings May Lead to New Ways to Study and Fight Diabetes

February 15, 2008 (EurekAlert) - Diabetes can be a killer, but the recent findings of four Texas A&M University researchers could lead to new ways to study and fight the dreaded disease.

Diabetics not only have high blood glucose (sugar) levels, they also have elevated fatty acid levels because they have trouble metabolizing glucose and fatty acids. In the past, scientists have studied the glucose and fatty acid aspects of diabetes separately because there was nothing linking them together.

Texas A&M researchers Heather Hostetler, Huan Huang, Ann Kier, and Friedhelm Schroeder, however, were able to link the two areas of study by identifying a single molecule in the nucleus of cells that regulates the metabolism of both glucose and fatty acids. The results of their study were recently published in the Journal of Biological Chemistry.

Scientists have long known that fatty acids bind with a protein called PPAR-alpha in the nucleus of cells. PPAR-alpha is a nuclear receptor, which means it is responsible for regulating the expression of specific genes. When fatty acids bind to PPAR-alpha, certain genes are turned on or off to control the metabolism of fatty acids.

Hostetler and her colleagues recently found that glucose also binds to PPAR-alpha, which presents an opportunity for scientists to study and understand one mechanism that regulates both glucose and fatty acid metabolism.

“This provides a direct link for the first time between fat and sugar metabolism and shows they are intimately linked and share the same receptor in the nucleus,” Schroeder said. “This could be a paradigm-shifter and cause people to rethink the way they look at diabetes because we now have a central player – PPAR-alpha – that’s impacted by both glucose and fatty acids.”

Normally, a hormone called insulin signals a person’s cells to take in and metabolize glucose. In diabetics, however, either not enough insulin is being produced or the person’s insulin receptors are not working. This causes some of the body’s cells to not take in glucose properly, and glucose builds up in the bloodstream, Kier explains.

Abnormally high levels of glucose in the bloodstream can severely damage a person’s blood vessels. Also, some cells in the body do not need insulin to take in glucose, and when high levels of glucose build up in these cells, it can lead to problems such as accelerated cardiovascular disease, kidney disease, nerve damage and damage to the retina of the eye.

Research conducted by Hostetler and her colleagues suggests that PPAR-alpha normally binds with both glucose and fatty acids in a very precise balance to regulate their metabolism. To metabolize fatty acids, PPAR-alpha breaks them up into small pieces and can then either burn them or make glucose out of them to store for later use, Schroeder explains.

When the balance is thrown off as it is in diabetics, however, the group’s research suggests that the high level of glucose over-stimulates PPAR-alpha, which causes it to malfunction and turn most of the fatty acid into glucose. This causes even more glucose to build up, which makes the situation even worse.

The group’s findings could also lead to the development of new drugs to prevent or reverse the harmful side effects of diabetes, which is the sixth leading cause of death in Texas. “All at once, it’s like a whole new ballgame,” Schroeder said. “The new findings open up a whole new potential class of therapeutic agents.”

One possibility is a drug that would block glucose from binding to PPAR-alpha, which would prevent PPAR-alpha from becoming over-stimulated and producing even larger amounts of glucose, Schroeder said. So far, the group has tested 1,040 drugs and found five that were able to reverse the harmful effects of high glucose on PPAR-alpha and restore the compound to its normal function.

The group hopes its findings will bring scientists together and lead to studying diabetes in a new way. “I think our findings will stimulate a lot more research that tries to understand fatty acids and glucose together, rather than in separate worlds,” Kier said. “This basic research is important because scientists can’t really progress until they go back and understand the process and how things happen physiologically.”

Posted by dlife at 02:37 PM | Comments (1)

Hispanics Have More Difficulty Controlling Diabetes Than Non-Hispanic Whites

February 15, 2008 (EurekAlert) - Results of an analysis of multiple studies show diabetes control is more challenging for Hispanics than non-Hispanic whites, according to researchers at Wake Forest University Baptist Medical Center and colleagues.

The results revealed that Hispanic patients with diabetes have approximately 0.5 percent higher levels on a test that measures blood sugar control, called the A1C test, than non-Hispanic white patients. The researchers noted the consistency of these findings across the studies.

An A1C test measures hemoglobin linked with glucose, or blood sugar, over a time period of two to three months. Higher A1C values indicate patients have difficulty controlling their blood sugar.

The results of the “meta-analysis” are reported in the February issue of Diabetes Care.

A meta-analysis combines the results of several studies that used similar methods and procedures. This allows the capability to generate larger numbers than from a single study and detect differences that didn’t show up in individual studies.

“These findings are interesting because they evaluate all available information from studies that include both Hispanic and non-Hispanic whites over a period of 13 years,” said Julienne Kirk, PharmD, associate professor of family and community medicine at Wake Forest University School of Medicine, and lead author of the study.

Kirk says that knowing some minority groups may have higher A1C could impact early treatment and awareness.

The researchers reviewed 495 studies, and narrowed their analysis down to 11 studies that comprised results of A1C tests for Hispanics and non-Hispanic whites, who were at least 18 years of age, and were not considered to have prediabetes or gestational diabetes.

According to the Centers for Disease Control and Prevention (CDC), the incidence per 1,000 of diagnosed diabetes of those between 18 and 79 years was 10.2 percent for Hispanic or Latino individuals compared with 6.9 percent for non-Hispanic whites in 2005.

“We were not surprised by these findings since ethnic minorities in the U.S. are disproportionately affected by diabetes, and we found a similar trend in the African American population with diabetes a year ago,” said Kirk. “What did surprise us were the results of our analysis of subgroups of patients with managed care and non-managed care insurance. The largest difference for A1C was among non-managed care insurance groups.”

The authors recommend development of strategies that focus not only on discovering the source of the differences in diabetes control between the two groups, but also on reducing these disparities.

“A high percentage of Hispanics in this country have low incomes, no health insurance, and limited access to health care,” said Kirk. “The Hispanic population has a high prevalence of diabetes and higher A1C than non-Hispanic whites. This further elucidates the health disparities that characterize the Hispanic population.”

Posted by dlife at 09:13 AM | Comments (1)

FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products

February 15, 2008 (FDA) - The U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion."

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.

The FDA's "Good Reprint Practices" draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications.

Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.

In addition, the draft guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article, and articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed.

The FDA retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved "new use," or whether such activities cause a product to be considered misbranded or adulterated under The Federal Food, Drug and Cosmetic Act.

The FDA welcomes public comments on the draft guidance. Typed comments should be submitted within 60 days of the Federal Register notice announcing the availability of the draft guidance.

Submit comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For single copies of the draft guidance, call 301-827-3360 or contact: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Room 14-101, HF-11, Rockville, MD 20857.

Posted by dlife at 09:10 AM | Comments (0)

Major International Diabetes Study Does not Confirm Increased Risk of Death Reported by US Trial

Preliminary Findings from the Largest-Ever Study of Treatments for Diabetes Provide no Evidence That Intensive Treatment to Lower Blood Glucose (Sugar) Increases Risk of Death

February 14, 2008 (PR Newswire) - Interim results from the ADVANCE Study, involving 11,140 high-risk patients with type 2 diabetes, provide no evidence of an increased risk of death among those patients receiving intensive treatment to lower blood glucose (sugar).

These findings contrast with those reported last week by the US National Heart Lung and Blood Institute suggesting that intensive glucose lowering treatment levels had increased the death rate among patients with diabetes recruited to the ACCORD trial.

ADVANCE was designed to answer two questions in patients with type 2 diabetes: first, does intensive treatment to lower blood pressure improve outcome; and second, does intensive treatment to reduce blood glucose improve outcome.

In September 2007, the ADVANCE Collaborative Group published evidence in The Lancet showing that the blood pressure lowering treatment had reduced the death rate among participants. In January 2008, the part of the study designed to assess the effects of the intensive treatment to reduce blood glucose was completed. As in ACCORD, this intensive treatment program was designed to lower blood glucose to levels below those usually recommended by clinical guidelines.

Chairman of the ADVANCE Data Monitoring and Safety Committee, Professor Rory Collins from the University of Oxford, said "The interim results from ADVANCE provide no confirmation of the adverse mortality trend reported from the ACCORD study." He also noted that the ADVANCE interim results were based on more than twice as much data and similar levels of glucose control as in ACCORD. The members of the Data Monitoring and Safety Committee are the only members of ADVANCE study team with access to the study results.

ADVANCE principal investigator, Professor Stephen MacMahon from The George Institute for International Health in Sydney, stated that "Due to the unexpected report from the ACCORD trial, we felt it was in the public interest for us to ask our Data Monitoring and Safety Committee to make a statement as to whether the available data from ADVANCE provide any support for the suggestion that intensive blood glucose lowering may increase mortality."

In ADVANCE, the intensive blood glucose lowering program aimed to reduce levels of haemoglobin A1c (a marker of long term blood glucose control) to below 6.5%. This treatment regimen included a sulfonylurea drug, gliclazide modified release, for all patients and a range of other drugs for those not reaching target blood glucose levels.

ADVANCE commenced in July 2001 and patients were treated and followed-up for an average of five years. The Data Monitoring and Safety Committee, comprising a panel of independent experts in the field, met every six months to review the study data for any safety issues or other concerns.

ADVANCE Management Committee Chairman, Professor John Chalmers, commented "Doctors and patients should feel reassured that the mortality trend reported by the ACCORD study has not been found in the interim results from ADVANCE. However, we need to await more definitive analyses and reports from both studies before drawing final conclusions."

"Final patient visits have been completed, and the ADVANCE study data base is close to finalisation. We expect to have definitive results soon," said Study Director, Dr Anushka Patel, from The George Institute. "At this stage, the Data Monitoring and Safety Committee have reviewed results that are more than 99% complete, so we are confident that the interim findings communicated here are a reliable guide to the final results."

ADVANCE was conducted by an independent collaborative group of medical researchers, with support from the National Health & Medical Research Council of Australia and the Paris-based, Institute de Recherche Internationales Servier.

Posted by dlife at 10:07 AM | Comments (2)

Concerns Raised by the Results of the ACCORD

February 13, 2008 (Press Release) - American Association of Clinical Endocrinologists (AACE) advises patients with diabetes to check with their physician regarding their own care, but to continue to maintain good control of their glucose levels.

AACE applauds the caution exercised by the National Heart, Lung and Blood Institute, and the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial investigators in stopping the intensive glycemic treatment arm of their study because of the recommendation of their Safety Committee. The decision was clearly based upon the finding that in their patients with a high risk for cardiovascular disease, after an observation period of an average of four years, the group with a treatment goal of an A1c of 6.4% or less had a higher overall mortality rate than the comparison group. Both treatment groups, however, had excellent care from outstanding health care teams and both groups had a significantly lower mortality rate than what has been reported for similar groups in other studies and in population studies.

In the intensive treatment group, 257 of the study patients died, as opposed to only 203 in the standard group, a difference of approximately 3 patients/1,000 participants/yr. These data were sufficient to lead the investigators to stop that arm of the study and to carefully study the differences. Their decision represented an appropriate protective response for the study participants, but, as often is the case, many questions remain regarding the meaning of these important findings.

For some patients with type 2 diabetes and a high degree of cardiovascular risk, the goal of an A1c of 6.4% or less led to a poorer outcome than those in the study with a less intensive effort to improve their glycemic control. Both groups actually improved significantly from the baseline, pre-study A1c levels, and the non-intensive group had a mean A1c of 7.5%, which is good control.

The factors that may have played a role in the relatively higher death rates of the intensive treatment group have not yet been elucidated. At this time we do not know whether the results could have been due to chance, since the hazard ratios and full statistical analysis are not yet available. Currently we have no information as to whether the patients with a more complicated regimen had more frequent errors in following the regimen, or more depression because of the increased degree of difficulty. We do know that they had a significantly higher incidence of severe hypoglycemia, but we do not know whether that incidence was important in causing errors in judgment that could have led to morbidity or death. We do not have an analysis of the higher incidence of sudden death in the intensive therapy group. How many of them were due to hypoglycemia, or how many may have been due to accidents? We do not yet know whether Continuous Glucose Monitoring Systems were used in any sub-group and whether this method of glucose monitoring would have been helpful in patients with higher cardiovascular risk who were on beta blockers and intensive therapy.

For the time being, it is best to be cautious in our recommendations with our patients. A target of an A1c of 6.4% or less may not be either possible, wise or safe in type 2 patients with a higher risk of cardiovascular disease or those with established cardiovascular disease. Since the risk/benefit ratio from any therapy will differ from patient to patient, the clinician will need to make individual judgments about what is most appropriate for them at any particular time in their clinical course.

In conclusion, we support the decision to stop the lower A1c target arm of the ACCORD trial prematurely because of the safety concerns. We are looking forward to learning more about the important details about these key findings. We encourage doctors to individualize the A1c target goals on patients with Type 2 diabetes at higher risk. An A1c target of 6.5% or less is useful for many, including patients with Type 1 diabetes, and probably Type 2 patients at lower cardiovascular risk, but this goal is clearly not appropriate for all type 2 patients. However, more data later today will be available to show the long-term value of intensive therapy for type 2 diabetes, and this story is far from finished.

Posted by dlife at 10:48 AM | Comments (0)

Researchers at BMC Find Disability Does Not Necessarily Follow Disease in Living to Old Age

February 11, 2008 (EurekAlert) - Researchers from Boston Medical Center’s (BMC) New England Centenarian Study report that for a substantial proportion of their centenarian subjects, avoiding age-related diseases (i.e. stroke, cardiovascular disease, diabetes) may not be the key to their longevity; rather, the avoidance of disability may be a key feature in their exceptional survival. These findings appear in the February 11th issue of Archives of Internal Medicine.

The researchers examined the health histories of 739 centenarians and found about one third of the subjects had age-related diseases for 15 or more years (age of onset prior to the age of 85). “We expected to find that nearly all centenarians have to compress the time they are sick towards the very end of their lives, otherwise how could they get to such old age"” asked senior author, Thomas Perls, MD, MPH, director, of BMC’s New England Centenarian Study and associate professor of medicine at Boston University School of Medicine. “One factor enabling the survival of these sick centenarians-to-be appears to be a delay or compression of their disability,” he added.

Seventy two percent of the male centenarians and 34 percent of the female centenarians in this “survivors-of-disease” group (centenarians who developed age-related diseases prior to age 85) scored in the independent range on the Barthel Activities of Daily Living Index at the age of 97 or older. According to the researchers, for a significant proportion of people surviving to extreme old age, compression of disability, rather than morbidity is a key feature of their ability to live such long lives.

“The ramifications of our findings are that among older people, morbidity and disability do not always go hand in hand,” said lead author Dellara Terry, MD, MPH, co-director of the New England Centenarian Study and assistant professor of medicine at Boston University School of Medicine. “Eventually being able to understand the underlying mechanisms for delaying disability in the presence of important age related diseases could lead to better prognostication and perhaps even therapies,” she added.

The researchers also found that though far fewer in number, male centenarians tend to have significantly better cognition and physical function than their female counterparts. One possible explanation for this may be that women are more resilient compared to men when it comes to aging. Thus, for a man to live to 100 or older, he must be in truly fantastic shape as close to the end of his life, whereas, the women can better handle living with age-related illnesses.

Posted by dlife at 10:45 AM | Comments (0)

Artificial Sweeteners Linked to Weight Gain

Cutting the connection between sweets and calories may confuse the body, making it harder to regulate intake

February 10, 2008 (EurekAlert) — Want to lose weight? It might help to pour that diet soda down the drain. Researchers have laboratory evidence that the widespread use of no-calorie sweeteners may actually make it harder for people to control their intake and body weight. The findings appear in the February issue of Behavioral Neuroscience, which is published by the American Psychological Association (APA).

Psychologists at Purdue University’s Ingestive Behavior Research Center reported that relative to rats that ate yogurt sweetened with glucose (a simple sugar with 15 calories/teaspoon, the same as table sugar), rats given yogurt sweetened with zero-calorie saccharin later consumed more calories, gained more weight, put on more body fat, and didn’t make up for it by cutting back later, all at levels of statistical significance.

Authors Susan Swithers, PhD, and Terry Davidson, PhD, surmised that by breaking the connection between a sweet sensation and high-calorie food, the use of saccharin changes the body’s ability to regulate intake. That change depends on experience. Problems with self-regulation might explain in part why obesity has risen in parallel with the use of artificial sweeteners. It also might explain why, says Swithers, scientific consensus on human use of artificial sweeteners is inconclusive, with various studies finding evidence of weight loss, weight gain or little effect. Because people may have different experiences with artificial and natural sweeteners, human studies that don’t take into account prior consumption may produce a variety of outcomes.

Three different experiments explored whether saccharin changed lab animals’ ability to regulate their intake, using different assessments –the most obvious being caloric intake, weight gain, and compensating by cutting back.

The experimenters also measured changes in core body temperature, a physiological assessment. Normally when we prepare to eat, the metabolic engine revs up. However, rats that had been trained to respond using saccharin (which broke the link between sweetness and calories), relative to rats trained on glucose, showed a smaller rise in core body temperate after eating a novel, sweet-tasting, high-calorie meal. The authors think this blunted response both led to overeating and made it harder to burn off sweet-tasting calories.

“The data clearly indicate that consuming a food sweetened with no-calorie saccharin can lead to greater body-weight gain and adiposity than would consuming the same food sweetened with a higher-calorie sugar,” the authors wrote.

The authors acknowledge that this outcome may seem counterintuitive and might not come as welcome news to human clinical researchers and health-care practitioners, who have long recommended low- or no-calorie sweeteners. What’s more, the data come from rats, not humans. However, they noted that their findings match emerging evidence that people who drink more diet drinks are at higher risk for obesity and metabolic syndrome, a collection of medical problems such as abdominal fat, high blood pressure and insulin resistance that put people at risk for heart disease and diabetes.

Why would a sugar substitute backfire? Swithers and Davidson wrote that sweet foods provide a “salient orosensory stimulus” that strongly predicts someone is about to take in a lot of calories. Ingestive and digestive reflexes gear up for that intake but when false sweetness isn’t followed by lots of calories, the system gets confused. Thus, people may eat more or expend less energy than they otherwise would.

The good news, Swithers says, is that people can still count calories to regulate intake and body weight. However, she sympathizes with the dieter’s lament that counting calories requires more conscious effort than consuming low-calorie foods.

Swithers adds that based on the lab’s hypothesis, other artificial sweeteners such as aspartame, sucralose and acesulfame K, which also taste sweet but do not predict the delivery of calories, could have similar effects. Finally, although the results are consistent with the idea that humans would show similar effects, human study is required for further demonstration.

Posted by dlife at 10:03 AM | Comments (2)

Study Confirms That Low-Calorie Sweeteners Are Helpful In Weight Control

Low-calorie sweeteners may be one piece in solving the obesity puzzle

February 8, 2008 (EurekAlert) - A recent review of the scientific literature concluded that low-calorie (or no-calorie) sweeteners may be of help in resolving the obesity problem. Although they are not magic bullets, low-calorie sweeteners in beverages and foods can help people reduce their calorie (energy) intakes. “Low-calorie sweeteners reduce the energy of most beverages to zero and lower the energy density of many foods,” said study co-author, Dr. Adam Drewnowski, Director, Center for Public Health Nutrition at the University of Washington. “Every dietary guideline these days tells us to bulk up, hydrate, and consume foods with fewer calories but more volume.”

The study by Bellisle and Drewnowski, published in the European Journal of Clinical Nutrition, evaluated a variety of laboratory, clinical and epidemiological studies on low-calorie sweeteners, energy density and satiety. Their findings, based on extensive studies with humans, are completely at odds with a new study on 27 Sprague-Dawley rats eating yogurt, published in the February issue of Behavioral Neuroscience.

The February study, “A Role for Sweet Taste: Caloric Predictive Relations in Energy Regulation by Rats,” alleges a link between low-calorie sweeteners and weight gain. However, previous studies in humans have shown that low-calorie sweeteners can be helpful in weight control. “Everything old is new again: similar studies on the uncoupling of sweetness and calories in humans were conducted back in 1989 – and to no great effect,” noted Drewnowski. Among criticisms of the study identified by nutrition experts were:

* Small sample size. The original clinical study by Rogers and Blundell (1989), not cited in this report, used 24 humans. The present study is based on 27 rats.

* Preabsorptive (“cephalic phase”) insulin release, the body’s supposed reaction to non-caloric sweet taste, is cited as the potential mechanism for overeating. The problem is that there is no cephalic phase insulin release in humans following the ingestion of aspartame, as demonstrated by Abdallah et al (1997) and not referenced here.

* A recent study, also based on rats, showed that any flavor associated with a lack of calories led to overeating – even salt. However, that effect was observed only in very young rats (4 weeks) and disappeared 4 weeks later.

* Findings in animal (e.g., rat) studies are not necessarily applicable to humans. Generally, clinical studies with humans follow animal studies. The present study went backwards.

* Some have blamed “sweet tooth” and sugar calories for rising obesity rates. Others now blame “sweet tooth” and the absence of sugar calories for rising obesity rates. The human desire for sweet taste is an innate reflex that is present at birth: it is not learned, it is not acquired, it is not conditioned – and it is not going away anytime soon.

“This study oversimplifies the causes of obesity,” said Beth Hubrich, a dietitian with the Calorie Control Council, an association representing low- and reduced-calorie foods and beverages. “The causes of obesity are multi-factorial. Although surveys have shown that there has been an increase in the use of ‘sugar-free’ foods over the years, portion sizes of foods have also increased, physical activity has decreased and overall calorie intake has increased,” she added.

Several studies conducted in humans have shown that low-calorie sweeteners and the products that contain them can be useful tools in weight control. For example, a study conducted by Dr. George Blackburn and published in the American Journal of Clinical Nutrition investigated whether the addition of aspartame to a multidisciplinary weight control program would improve weight loss and long-term control of body weight in obese women. One hundred sixty-eight obese women aged 20 to 60 years were studied over a two-year period. The researchers found that participation in this multidisciplinary weight control program including the use of aspartame-sweetened foods and beverages not only facilitated weight loss, but long-term maintenance of a reduced body weight.

A 2007 study published in Pediatrics found that using sucralose or sucralose sweetened beverages as well as increasing activity helped maintain and lower body mass index for children participating in the “Families on the Move” program. Additionally, a study published in the Journal of Food Science found that people who use reduced-calorie products (containing low-calorie sweeteners) not only had a better quality diet but also were more likely to consume fewer calories than those who did not use reduced-calorie products.

“Rising obesity rates have now been linked to the presence of sugars in the food supply and to the absence of sugars from the food supply,” noted Drewnowski. “Consumers find it difficult to know who to believe. In the final analysis, all health experts agree that weight loss is best achieved by a combination of reducing caloric intake, lowering energy density of the diet, and increasing physical activity. By all accounts, low-calorie sweeteners do help. Suggesting that low-calorie sweeteners actually cause people to gain weight is an irresponsible direct application of rat models to dietary counseling and to public health.”

Posted by dlife at 09:41 AM | Comments (2)

Statement from the American Diabetes Association Related to ACCORD Trial Announcement

ACCORD data raises concerns; Group advises patients with diabetes to maintain good control of blood glucose and talk to their doctor

February 7, 2008 (PRNewswire-USNewswire) - In response to today's announcement by the National Heart, Lung, and Blood Institute, which sponsors the ACCORD (Action to Control Cardiovascular Risk in Diabetes) Trial to stop the intensive blood glucose (sugar) control sub-study in ACCORD due to safety concerns, the American Diabetes Association strongly encourages people with diabetes not to alter their course of treatment without first consulting with their health care team. The American Diabetes Association continues to encourage good control of blood glucose for the management of diabetes and its complications.

The ACCORD trial randomized patients with diabetes and vascular disease or multiple cardiovascular risk factors to an intensive treatment program targeting normal blood glucose values and an A1C less than 6 percent or a standard treatment program with an A1C between 7 percent and 7.9 percent. The intensive participants in ACCORD are now being switched to the standard treatment program because of an increased death rate in the intensive treatment program (14 deaths per 1000 patients per year versus 11 per 1000 patients per year in the standard treatment program; a difference of 0.3 deaths per 100 patients per year).

The American Diabetes Association continues to advise people with diabetes to strive for an A1C (a measure of long-term blood glucose control) of less than 7 percent. Recent data indicates that more than half of the population with diabetes in the U.S. have an A1C less than 7 percent and this overall level of glucose control appears to be of great benefit rather than harm.

The importance of glucose control in diabetes is firmly established. Evidence from the landmark Diabetes Control and Complications Trial (DCCT), and the U.K. Prospective Diabetes Study (UKPDS) show that improved glucose control to a level of approximately 7 percent reduces the complications of diabetes dramatically.

The Association's treatment guidelines also state that treatment should be tailored to the individual patient and that for some people with diabetes, intensive glucose control may not be warranted. Of note, the American Diabetes Association (in its Standards of Medical Care) states: "Less stringent A1C goals may be appropriate for patients with a history of severe hypoglycemia, patients with limited life expectancies, children, individuals with comorbid conditions, and those with longstanding diabetes and minimal or stable microvascular complications."

This recent announcement by ACCORD investigators suggests that very intensive glucose lowering treatment aimed at normalizing blood glucose (A1C<6%) may be detrimental, at least in middle-aged and older adults with vascular disease or multiple risk factors for vascular disease. The exact reason for the increased death rates with intensive treatment that occurred in ACCORD is not yet known. However, an analysis of the ACCORD data indicates that the detrimental effect of intensive therapy was not due to hypoglycemia or any specific combination of drug therapies.

The American Diabetes Association looks forward to more analysis of the data from ACCORD, as well as other ongoing studies that may shed more light on this issue. However, at this time, the American Diabetes Association advises people with diabetes who have existing cardiovascular disease (CVD), or multiple CVD risk factors, to consult with their health care team about their treatment goals and to ensure that their blood pressure and cholesterol are appropriately managed.

Posted by dlife at 09:42 AM | Comments (3)

For Safety, NHLBI Changes Intensive Blood Sugar Treatment Strategy in Clinical Trial of Diabetes and Cardiovascular Disease

February 6, 2008 (NIH Press Release) - The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped one treatment within a large, ongoing North American clinical trial of diabetes and cardiovascular disease 18 months early due to safety concerns after review of available data, although the study will continue.

In this trial of adults with type 2 diabetes at especially high risk for heart attack and stroke, the medical strategy to intensively lower blood glucose (sugar) below current recommendations increased the risk of death compared with a less-intensive standard treatment strategy. Study participants receiving intensive blood glucose lowering treatment will now receive the less-intensive standard treatment.

The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study enrolled 10,251 participants. Of these, 257 in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year, over an average of almost four years of treatment. The death rates in both groups were lower than seen in similar populations in other studies.

"A thorough review of the data shows that the medical treatment strategy of intensively reducing blood sugar below current clinical guidelines causes harm in these especially high-risk patients with type 2 diabetes," said Elizabeth G. Nabel, M.D., director, NHLBI. "Though we have stopped this part of the trial, we will continue to care for these participants, who now will receive the less-intensive standard treatment. In addition, we will continue to monitor the health of all participants, seek the underlying causes for this finding, and carry on with other important research within ACCORD."

In stopping this part of the trial, Nabel accepted the recommendation of the 10-member Data and Safety Monitoring Board (DSMB) — an independent advisory group of experts in diabetes, cardiovascular disease, epidemiology, patient care, biostatistics, medical ethics, and clinical trial design that has been monitoring ACCORD since it began. A specific charge of any DSMB is to monitor participant safety.

ACCORD participants will continue to receive blood sugar treatment from their study clinicians until the planned trial conclusion in June 2009. Those participants in the intensive treatment group will now be treated to the same A1C goals as those already in the standard treatment group.

The intensive treatment group had a target blood sugar goal, measured by hemoglobin A1C, of less than 6 percent. This is similar to blood sugar levels in adults without diabetes. The standard treatment group aimed for a target similar to what is achieved, on average, by those with diabetes in the United States (A1C of 7 to 7.9 percent) and lower than at study entry.

"The ACCORD findings are important, but will not change therapy for most patients with type 2 diabetes. Few patients with high cardiovascular risk like those studied in ACCORD are treated to blood sugar levels as low as those tested in this study, " said Judith Fradkin, M.D., director, Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). "People with diabetes should never adjust their treatment plan or goals without consulting their health care providers."

In ACCORD, intensive treatment group participants achieved, on average, A1C values lower than standard treatment group participants. Half of the participants in the intensive treatment group achieved an A1C of less than 6.4 percent, and half of the participants in the standard treatment group achieved an A1C of less than 7.5 percent. The average blood sugar levels for both groups were lower than when they entered the study.

The ACCORD trial was designed to determine whether intensively lowering blood sugar would reduce the risk of cardiovascular events such as heart attack, stroke, or death from cardiovascular disease, specifically in people with type 2 diabetes who are at particularly high risk for a cardiovascular event. Prior studies suggested that reducing blood sugar to levels found in non-diabetic adults may reduce the rate of cardiovascular diseases among those with diabetes. However, a randomized clinical trial was needed to determine whether that hypothesis is accurate.

"ACCORD is an important study intended to find new answers to help people with type 2 diabetes reduce their high risk of heart disease," said Denise G. Simons-Morton, M.D., Ph.D., NHLBI project officer for ACCORD and a member of the ACCORD steering committee. "Hypotheses about treatments to prevent cardiovascular disease in people with type 2 diabetes need to be tested in clinical trials such as ACCORD. The ACCORD results, along with results from other studies, will contribute to determining what the treatment goals should be in patients with various characteristics."

Conducted at 77 sites nationwide and in Canada, the trial includes adults between the ages of 40 and 82 at enrollment who, in addition to type 2 diabetes, also have two or more other risk factors for heart disease or had been diagnosed with heart disease before entering the study. Thus, participants were included in the ACCORD trial because they were at especially high risk — more risk than is associated with diabetes alone — for having a heart attack, stroke, or of dying from cardiovascular disease. Participants, who on average had diabetes for 10 years at enrollment, were randomly assigned to either standard (5,123 participants) or intensive (5,128) blood sugar treatment goals. They were also enrolled in one of two other ACCORD randomized clinical trials examining effects of treatments for blood pressure or blood lipids; those study components will continue. Participants had been followed for 2 years to 7 years at the time the intensive blood sugar control treatment was stopped.

These results from ACCORD do not apply to patients with type 1 (juvenile) diabetes, according to Fradkin. It is also unclear whether the results apply to patients with recently diagnosed type 2 diabetes or those whose cardiovascular risk is lower than the participants studied in ACCORD.

Extensive analyses by ACCORD researchers have not determined a specific cause for the increased deaths among the intensive treatment group. Based on analyses conducted to date, there is no evidence that any medication or combination of medications is responsible.

Most participants in the intensive treatment group achieved their lower blood sugar goals with combinations of Food and Drug Administration-approved diabetes medications. For both the intensive and standard treatment groups, study clinicians could use all major classes of diabetes medications available: metformin, thiazolidinediones (TZDs, primarily rosiglitazone), insulins, sulfonylureas, exanatide, and acarbose.

"Because of the recent concerns with rosiglitazone, our extensive analysis included a specific review to determine whether there was any link between this particular medication and the increased deaths. We found no link," said William T. Friedewald, M.D., ACCORD Steering Committee Chair and Clinical Professor of Medicine and Public Health at Columbia University.

ACCORD researchers will continue to monitor participants and conduct additional analyses to try and explain the findings. Investigators are preparing a report of the findings for a peer-reviewed publication.

An estimated 21 million Americans have diabetes and 284,000 die from it each year. Sixty-five percent of the deaths are related to cardiovascular causes. Type 2 diabetes increases the risk for heart disease 2 to 4 times.

The National Diabetes Education Program, a program of the NIDDK and the Centers for Disease Control and Prevention (CDC), promotes the diabetes care guidelines of the American Diabetes Association (ADA), which recommend an A1C goal of less than 7 percent for most people with type 2 diabetes. The ADA guidelines are based on established evidence that blood sugar control to this level reduces microvascular complications resulting from diabetes including eye, kidney, and nervous system diseases in people with type 1 or type 2 diabetes, and reduces cardiovascular disease in type 1 diabetes. The guidelines also state that treatment goals should be tailored to the individual. For example, a less stringent A1C goal should be considered for people with severe or frequent low blood sugar or with other medical conditions. These important ACCORD results can now be considered in addition to the guidelines when individualizing treatment.

NIDDK contributed funding and scientific expertise to ACCORD. The NIH's National Institute of Aging and National Eye Institute, as well as the CDC, are also contributing in order to conduct sub-studies in ACCORD. The following companies provided study medications, equipment, or supplies: Abbott Laboratories, Amylin Pharmaceuticals, AstraZeneca LP, Aventis Pharmaceuticals, Inc., Closer Healthcare, GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals, Inc., MediSense Products (Division of Abbott Laboratories), Merck & Company, Inc., Novartis Pharmaceuticals, Inc., Novo Nordisk Pharmaceuticals, Inc., and Omron Healthcare, Inc.

To arrange an interview with an NHLBI spokesperson, please contact the NHLBI Communications Office at (301) 496-4236 or email nhlbi_news@nhlbi.nih.gov. To interview Dr. Friedewald on Wednesday, please contact NHLBI; after February 6, contact Randee Sacks Levine at Columbia University Office of Communications at 212-305-8044.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Posted by dlife at 11:29 AM | Comments (3)

National Survey Shows Minority Children Experience Multiple Disparities in health car

February 6, 2008 (Press Release) - There is a lack of equity in health care for minority children in America, according to data gathered in a nationwide survey and analyzed by a UT Southwestern Medical Center researcher.

The UT Southwestern analysis, available online and published as an abstract in the February issue of the journal Pediatrics, suggests certain disparities are particularly pronounced for specific racial and ethnic groups. Awareness of these disparities may be useful for clinicians, health systems and policymakers to address the needs of diverse populations, said Dr. Glenn Flores, professor of pediatrics at UT Southwestern and lead author of the study.

"Greater attention needs to be paid to disparities in minority children, not just because of their striking frequency and magnitude, but also because of their potential to become disparities in adults," said Dr. Flores. "Conservative estimates indicate that minorities will comprise half of U.S. children by 2040. In Texas, more than 62 percent of children currently are non-white. Although increasing attention is being paid to racial and ethnic disparities in health care, very little attention is directed toward children."

Results were drawn from the National Survey of Children's Health (NSCH). Conducted by the Centers for Disease Control and Prevention's National Center for Health Statistics, the NSCH was a national telephone survey of 102,353 interviews completed between January 2003 and July 2004. One child under the age of 18 was randomly selected in each household as the subject of the survey. The parent or guardian who knew the most about the child's health and health care served as the res