Crestor Outcomes Study JUPITER Closes Early Due To Unequivocal Evidence Of Benefit

March 31, 2008 (Press Release) - AstraZeneca today announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.

JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was designed to determine if treating patients with no evidence of pre-existing cardiovascular disease and low to normal LDL-C but elevated C-reactive protein (CRP) with CRESTOR 20mg once daily would reduce major cardiovascular events. CRP is a recognized marker of inflammation and is associated with an increased risk of atherosclerotic cardiovascular events.

The JUPITER study team has initiated activities to close this large multi-centre study. Over 15,000 trial participants will be scheduled by their investigator for final assessments at over 1,200 sites in 26 countries. Data from these visits will be collected and reviewed to allow a full and complete analysis and final results of the study will be published once the analysis is complete.

JUPITER is one study from the global research initiative known as the GALAXY programme, which has now recruited more than 64,000 patients from 55 countries worldwide, to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes.

Posted by dlife at 03:22 PM | Comments (1)

Landmark ONTARGET(TM) Trial Demonstrates Micardis(R) is Equally Effective as Ramipril, with Fewer Discontinuations, in a Broad High-Risk Cardiovascular Population

March 31, 2008 (PRNewswire) -- The results of the landmark ONTARGET(TM) trial have demonstrated that MICARDIS(R) (telmisartan), a second-generation angiotensin II receptor blocker (ARB), is equally effective as the current standard, ramipril, in reducing the risk of cardiovascular death, myocardial infarction, stroke and hospitalization for congestive heart failure in a broad cross-section of high-risk cardiovascular patients with normal blood pressure or controlled high blood pressure, and resulted in fewer discontinuations.(1) These cardiovascular events occurred in 1,423 patients (16.7 percent) receiving telmisartan versus 1,412 patients (16.5 percent) receiving ramipril.(1) The relative
risk (ratio of the probability of the event occurring in the telmisartan group versus the ramipril group) was 1.01, with a 95 percent CI of 0.94 -1.09.

Telmisartan is now the only ARB to have demonstrated cardio and vascular risk reduction benefits beyond lowering blood pressure in this high-risk population;(1) these benefits may be attributed to the specific pharmacological properties and mode of action of the drug. Previously, in 2000, the HOPE trial showed that the cardiovascular risk for patients treated with the angiotensin-converting enzyme (ACE) inhibitor ramipril was reduced by approximately 20 percent compared with placebo.(2) This meant
that every fifth serious cardiovascular event in a high risk group of patients was prevented.(2)

"The ONTARGET trial shows that telmisartan is a well-tolerated treatment in high-risk cardiovascular patients that is as effective as ramipril in preventing heart attacks, stroke and hospitalizations for heart
failure and deaths," said Professor Salim Yusuf, lead investigator of the ONTARGET Trial Program and Director of the Population Health Research Institute at McMaster University, Hamilton, Canada. "The ONTARGET results have important implications for the management of patients with cardiovascular diseases."

In this trial, which was based on the HOPE study design, the benefits of telmisartan were demonstrated in a large group (8,542) of high-risk patients who were already receiving standard care such as statins to lower cholesterol, antiplatelet therapy, beta blockers and other antihypertensives.(3) Telmisartan treatment led to fewer discontinuations than treatment with ramipril, a widely used ACE inhibitor.(1) Although patients with an ACE inhibitor intolerance had been excluded from the trial, 360 (4.2 percent) patients in the ramipril treatment arm stopped their treatment because they experienced cough, a common ACE inhibitor side effect, versus only 93 (1.1 percent) patients in the telmisartan arm. Twenty-five patients stopped their treatment in the ramipril arm because of angioedema, versus only 10 in the telmisartan arm.(1) The incidence of hypotension was higher in the telmisartan arm (229 patients, 2.7 percent) versus the ramipril (149 patients, 1.7 percent) arm.(1)

"Boehringer Ingelheim is proud to have supported ONTARGET(TM), the largest cardiovascular outcomes trial of its kind and the first of a series of landmark clinical studies sponsored by our company. NTARGET is just one example of Boehringer Ingelheim's leadership in trying to address the needs
of people with cardiovascular disease," commented J. Martin Carroll, president and chief executive officer of Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to pursuing further research that
evaluates ways to reduce the risk of damaging events in the heart, brain and other organs due to cardiovascular disease and to uncover new treatment strategies that may improve patient outcomes and care."

ONTARGET also studied the value of combining telmisartan with ramipril, to evaluate whether combining an ACE inhibitor and an ARB, i.e. the dual renin-angiotensin system (RAS) blockade, could offer even etter risk reduction compared to single blockade, a key question for the clinical community. The results announced today indicate that there was no additional risk reduction benefit achieved and a higher discontinuation rate if telmisartan and ramipril are combined.(1)

About the ONTARGET(TM) Trial Program

The ONTARGET Trial Program is the largest clinical trial ever undertaken with an ARB, involving more than 31,000 high-risk cardiovascular patients with either normal or controlled blood pressure. The ONTARGET Trial Program encompasses two randomized, double-blind, multi-center international outcome trials: ONTARGET, the main trial with results reported today, and TRANSCEND(TM) (Telmisartan Randomized Assessment Study in ACE-intolerant subjects with cardiovascular disease), the parallel trial
with results planned to be reported later in 2008.

ONTARGET evaluated more than 25,600 high-risk cardiovascular patients with normal blood pressure or controlled high blood pressure and a history of a broad range of cardiovascular diseases. The study compared the effectiveness of the ARB telmisartan to the ACE inhibitor ramipril in reducing the combined risk of cardiovascular death, myocardial infarction, stroke and hospitalization for congestive heart failure (CHF) in patients at risk. The study also compared the efficacy of the combination of the ARB
telmisartan and the ACE inhibitor ramipril compared to ramipril alone in achieving the same combined endpoint.

The combined primary endpoint in the ONTARGET trial included cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure. In addition, a broad variety of secondary and tertiary endpoints were studied, including: newly diagnosed diabetes, cognitive decline/dementia, nephropathy, atrial fibrillation and left ventricular hypertrophy.

Treatment arms for the ONTARGET(TM) trial were telmisartan 80 mg, ramipril 10 mg and a combination therapy with telmisartan 80 mg and ramipril 10 mg. All treatments were applied in addition to standard care for high-risk cardiovascular patients.

More than 700 sites throughout Asia, Australia, New Zealand, Europe, North/South America and South Africa participated in the ONTARGET Trial Program. The ONTARGET Steering Committee consists of scientists from McMaster University in Ontario, Canada; Oxford University in Oxford, England; the University of Auckland in Auckland, New Zealand; and Boehringer Ingelheim.

The ONTARGET trial was investigational and was conducted to expand scientific knowledge of telmisartan. Note that the trial included treatment for conditions outside the approved indication for telmisartan.

Posted by dlife at 03:15 PM | Comments (0)

New data showed Actos Prevented Progression of Atherosclerotic Plaque Volume in Patients

March 31, 2008 (EurekAlert) - New data from a clinical trial using intravascular ultrasound (IVUS) technology found that in patients living with type 2 diabetes, ACTOS® (pioglitazone HCl) reduced the atherosclerotic burden in the coronary arteries compared to glimepiride, and prevented progression compared to baseline. These data stem from the PERISCOPE (Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation) trial.

The PERISCOPE trial was presented today as a late breaker at the 57th Annual Scientific Session of the American College of Cardiology in Chicago. This trial adds to the body of cardiovascular data for ACTOS. ACTOS studies, conducted over the past 10 years in more than 16,000 patients, including short- and long-term trials, as well as prospective and observational studies, have shown no evidence that ACTOS is associated with an increased risk of heart attack, stroke, or death.

“We are pleased with the results of the PERISCOPE, which further expands our cardiovascular data with ACTOS,” said David P. Recker, M.D., senior vice president, Clinical Sciences and interim president at Takeda Global Research & Development. “While not definitive, data from PERISCOPE combined with results from a previous study, looking at surrogate endpoints, have shown a consistent trend toward decreasing cardiovascular risk by reducing the atherosclerotic burden in people with type 2 diabetes.”

PERISCOPE is the first clinical trial to examine the effects of an oral antidiabetic medication on the development of coronary atherosclerosis in patients with type 2 diabetes using IVUS technology. The trial conducted in 97 centers in the U.S., Canada and Latin America with 543 patients, used IVUS imaging of the coronary arteries. The analysis demonstrated a statistically significant difference in percent change in coronary artery atheroma volume in favor of ACTOS treatment compared to glimepiride treatment.

The data showed that patients treated with glimepiride, a sulfonylurea and commonly used diabetes medication, exhibited progression of coronary atherosclerosis. In contrast, the ACTOS arm showed no progression of coronary atherosclerosis over the 18-month period from the initial baseline measurement.

Cardiovascular safety data was collected by looking at macrovascular events and episodes of congestive heart failure (CHF). The number of episodes of a common cardiovascular endpoint of cardiovascular mortality, non-fatal MI, or non-fatal stroke was 6 (2.2%) in glimepiride patients and 5 (1.9%) in ACTOS-treated patients. The number of hospitalizations due to CHF was equivalent in both arms. In the ACTOS-treated group, eight patients experienced a bone fracture, none involving the hip or spine.

Atherosclerosis is a condition that leads to reduced or blocked blood flow, and is accelerated in patients with type 2 diabetes. Atherosclerosis-related cardiovascular disease is the leading cause of death and disability in people with type 2 diabetes. Published data shows that slowed progression and reductions in atheroma volume lessens the incidence of a second heart attack. IVUS measures the volume of plaque build-up in the coronary arteries, a marker of coronary atherosclerosis.

The data are consistent with the findings of the CHICAGO (Carotid intima-media tHICkness in Atherosclerosis using pioGlitazOne) trial. Both PERISCOPE and CHICAGO support the findings of the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) trial, which showed that ACTOS was not associated with an increased risk of heart attack, stroke or death.

Posted by dlife at 12:13 PM | Comments (0)

Tai Chi Exercises Improve Type 2 Diabetes Control

March 31, 2008 (Newswise) — Tai Chi exercises can improve the control of type 2 diabetes, suggests a small study, published ahead of print in the British Journal of Sports Medicine.

Tai Chi Chuan is a traditional Chinese martial art, which combines deep diaphragmatic breathing and relaxation with gentle movement.

The research team assessed the impact of a 12 week programme of Tai Chi exercises on the T helper cell activity of 30 patients with type 2 diabetes and 30 healthy people of the same age.

T cells are a key component of the body’s immune system, producing powerful chemicals, including interleukins, which alter the immune response.

Type 2 diabetes is associated with chronic inflammation, caused by excessive glucose in the blood (hyperglycaemia).

After the 12 week programme glycated haemoglobin (when excess blood sugar combines with the oxygen transporter in red blood cells) levels fell significantly from 7.59% to 7.16 in the diabetic patients.

And levels of interleukin-12, which boosts the immune response, doubled. Levels of interleukin-4, which suppresses the immune response, fell.

T cell activity also significantly increased.

Strenuous physical activity depresses the immune system response, but moderate exercise seems to have the opposite effect, say the authors. Tai Chi is classified as moderate exercise.

Previous research has shown that it boosts cardiovascular and respiratory function, as well as improving flexibility and relieving stress, they add.

Tai Chi may prompt a fall in blood glucose levels, or improve blood glucose metabolism, sparking a drop in the inflammatory response.

Alternatively, the exercise may boost fitness levels and the feeling of wellbeing, which may then boost the health of the immune system, they suggest.

In a separate study, also published ahead of print, a 12 week programme of Tai Chi and Qigong (another Chinese exercise) prompted a significant fall in blood glucose levels and significant improvements in other indicators of the metabolic syndrome in 11 middle aged to older adults.

The metabolic syndrome is a cluster of symptoms, including high blood pressure and high blood glucose that is associated with increased risks of cardiovascular disease and diabetes.

The 13 participants exercised for up to 1.5 hours, up to three times a week, and were also encouraged to practice the exercises at home.

At the end of the 12 weeks, they had lost an average of 3 kg in weight and their waist size had dropped by an average of almost 3 cm.

Their blood pressure also fell significantly, and by more than would have been expected from the weight loss alone, say the authors.

Insulin resistance-whereby cells stop responding to insulin http://www.medterms.com/script/main/art.asp?ArticleKey=3989 , a condition preceding full diabetes-also improved significantly.

Three people no longer met the criteria for metabolic syndrome.

Participants said they slept better, had more energy, felt less pain and had fewer food cravings while on the programme.

Posted by dlife at 10:18 AM | Comments (7)

Potential Association of Type 2 Diabetes Genes with Prostate Cancer

March 30, 2008 (EurekAlert) - Scientists have identified six new genes which play a role in the development of type 2 diabetes, and among the group is the second gene known to also play a role in prostate cancer.

The new findings bring the total number of genes or genomic regions implicated in diabetes to 16, said Laura Scott, assistant research scientist in the Department of Biostatistics. Researchers from the University of Michigan were one of three teams of scientists in Europe and North America that led the multi-group collaboration. The findings, which were published today in the journal Nature Genetics, provide new insights into the mechanisms which are usually responsible for the control of glucose, or sugar, levels in the blood, and to the derangements that can result in type 2 diabetes, which impacts more than 170 million people worldwide.

One of the newly discovered genes, which goes by the name of JAZF1, contains a separate variant that has recently been shown to play a role in prostate cancer, and is the second gene that appears to play a role in both conditions. The first identified overlap between genes for prostate cancer and type 2 diabetes was with HNF1B, which is also involved in an early onset form of diabetes discovered at U-M in an unrelated study, called Maturity Onset Diabetes of the Young (MODY). In HNF1B, the same variant that is associated with increased risk of diabetes is associated with decreased risk of prostate cancer. In JAZF1, the diabetes and prostate cancer variants reside in different parts of the gene and there is no known relationship between them.

"Some of these genes for type 2 diabetes might be involved in diseases other than prostate cancer, in fact there is already a known overlap with heart disease in another genomic region? Scott said. "We have about 25,000 genes, and we've found a very small number by genome wide studies, so to have the same genomic regions come up in studies of different diseases is actually pretty interesting."

Type 2 diabetes is characterized by high levels of blood sugar, caused by the body's inability to utilize insulin to move blood sugar into the cells for energy. Type 2 diabetes affects nearly 21 million in the United States and the incidence of the disease has skyrocketed in the last 30 years. Diabetes is a major cause of heart disease and stroke, as well as the most common cause of blindness, kidney failure and amputations in U.S. adults.

"The remarkable recent progress in identifying regions of the genome that increase risk to diabetes---from 3 to 16 in only a year---will help us unravel the complex basis diabetes and may suggest new and better tailored methods to prevent or treat this disease.," said U-M's Michael Boehnke, the lead scientist on the Finland-United States Investigation of Non-Insulin-Dependent Diabetes Mellitus Genetics (FUSION) study group, one of the three lead groups in the study.

The researchers in this project set out to find differences in the genetic code that contribute to individual differences in susceptibility to disease. Previous efforts from these groups and others identified ten genes contributing to type 2 diabetes risk.

Posted by dlife at 10:16 AM | Comments (0)

Once-Daily Basal Insulin Glargine vs. Thrice-Daily Prandial

Insulin glargine as good at controlling blood sugar as insulin lispro but simpler and more liked by patients

March 27, 2008 (EurekAlert) - The use of insulin glargine, (a single injection of daily insulin) is as effective at controlling blood sugar for people with diabetes as insulin lispro (which has to be injected up to three times a day), and is associated with increased satisfaction among users. These are the conclusions of authors of an Article published in this week’s edition of The Lancet.

The use of insulin glargine, (a single injection of daily insulin) is as effective at controlling blood sugar for people with diabetes as insulin lispro (which has to be injected up to three times a day), and is associated with increased satisfaction among users. These are the conclusions of authors of an Article published in this week’s edition of The Lancet.

Controlling blood sugar can help people with diabetes avoid the occurrence of microvascular events (eg, retinopathy) and, to a lesser extent, macrovascular complications. Blood sugar control is measured using the concentration of haemoglobin A1c in the blood, and concentrations less than 7% (optimally less than 6.5%) can substantially reduce the risk of these complications. The amount of haemoglobin A1c is directly related to the amount of sugar in the blood.

Professor Reinhard G Bretzel, Justus-Liebig-Universität Giessen, Germany, and colleagues did the APOLLO study, a 44-week trial of 418 patients with type 2 diabetes in 69 study sites across Europe and Australia. All patients had diabetes that was not adequately controlled by oral hypoglycaemic drugs, and were randomly assigned to either insulin glargine injected once daily at the same time every day (205 individuals), or to insulin lispro injected three times per day (210).

The investigators found that both groups achieved similar reductions in haemoglobin A1c, with the average decrease in the insulin glargine group -1.7% (from 8.7% to 7.0%); in the insulin lispro group the average decrease was -1.9% (from 8.7% to 6.8%).

The authors conclude: “A therapeutic regimen involving the addition of either basal or prandial insulin analogue is equally effective in lowering haemoglobin A1c. We conclude that insulin glargine provides a simple and effective option that is more satisfactory to patients than is lispro for early initiation of insulin therapy, since it was associated with a lower risk of hypoglycaemia, fewer injections, less blood glucose self monitoring, and greater patient satisfaction than was insulin lispro.”

Posted by dlife at 10:13 AM | Comments (0)

A Ton of Bitter Melon Produces Sweet Results for Diabetes

March 26, 2008 (EurekAlert) - Scientists have uncovered the therapeutic properties of bitter melon, a vegetable and traditional Chinese medicine, that make it a powerful treatment for Type 2 diabetes.

Teams from the Garvan Institute of Medical Research and the Shanghai Institute of Materia Medica pulped roughly a tonne of fresh bitter melon and extracted four very promising bioactive components. These four compounds all appear to activate the enzyme AMPK, a protein well known for regulating fuel metabolism and enabling glucose uptake. The results are published online today in the international journal Chemistry & Biology.

“We can now understand at a molecular level why bitter melon works as a treatment for diabetes,” said Professor David James, Director of the Diabetes and Obesity Program at Garvan. “By isolating the compounds we believe to be therapeutic, we can investigate how they work together in our cells.”

People with Type 2 diabetes have an impaired ability to convert the sugar in their blood into energy in their muscles. This is partly because they don’t produce enough insulin, and partly because their fat and muscle cells don’t use insulin effectively, a phenomenon known as ‘insulin resistance’.

Exercise activates AMPK in muscle, which in turn mediates the movement of glucose transporters to the cell surface, a very important step in the uptake of glucose from the circulation into tissues in the body. This is a major reason that exercise is recommended as part of the normal treatment program for someone with Type 2 diabetes.

The four compounds isolated in bitter melon perform a very similar action to that of exercise, in that they activate AMPK.

Garvan scientists involved in the project, Drs Jiming Ye and Nigel Turner, both stress that while there are well known diabetes drugs on the market that also activate AMPK, they can have side effects.

“The advantage of bitter melon is that there are no known side effects,” said Dr Ye. “Practitioners of Chinese medicine have used it for hundreds of years to good effect.”

Garvan has a formal collaborative arrangement with the Shanghai Institute of Materia Medica. In addition to continuing to work together on the therapeutic potential of bitter melon, we will be exploring other Chinese medicines.

Professor Yang Ye, from the Shanghai Institute and a specialist in natural products chemistry, isolated the different fractions from bitter melon and identified the compounds of interest.

“Bitter melon was described as “bitter in taste, non-toxic, expelling evil heat, relieving fatigue and illuminating” in the famous Compendium of Materia Medica by Li Shizhen (1518-1593), one of the greatest physicians, pharmacologists and naturalists in China’s history,” said Professor Ye. “It is interesting, now that we have the technology, to analyse why it has been so effective.”

“Some of the compounds we have identified are completely novel. We have elucidated the molecular structures of these compounds and will be working with our colleagues at Garvan to decipher their actions at a molecular level. We assume it’s working through a novel pathway inside cells, and finding that pathway is going to be very interesting.”

Posted by dlife at 01:56 PM | Comments (6)

Reduced Lung Capacity Accelerates with Diabetes

March 26, 2008 (Newswise) — People who have diabetes encounter a faster loss of lung capacity than those who do not have diabetes, a finding that may have implications for the potential use of inhaled insulin, according to a study appearing in the April issue of Diabetes Care.

The April issue also contains a consensus statement from the American Diabetes Association and American College of Cardiology Foundation emphasizing the need for more aggressive goals in controlling lipids to reduce cardiometabolic risk. In particular, the paper focuses for the first time on the need to test for and treat high levels of a protein called apolipoprotein B (ApoB), a more direct measure of the number of LDL particles that lead to plaques that cause heart disease (atherosclerosis). This is based on evidence that levels of ApoB are a better indicator of heart disease risk than total cholesterol or LDL (“bad cholesterol”).

Reduced Lung Capacity in People with Diabetes

The lung research, part of a larger investigation known as the Atherosclerosis Risk in Communities (ARIC) study, confirmed previous suggestions that the lung is a target organ for diabetic injury and that lung abnormalities accelerate once diabetes takes hold. Previous research by the same authors established that decreased lung capacity precedes and may predict a diagnosis of diabetes. The new study is accompanied by an editorial that concludes that diminished lung function may contribute to diabetes morbidity and mortality.

Specifically, the study found that people with type 2 diabetes experienced a more rapid decline in forced vital capacity, the measure of how well the lungs fill with air, than people who did not have diabetes. Though all people experience a decline in forced vital capacity as they age, people with diabetes appear to undergo a more rapid loss that appears before the diabetes diagnosis and accelerates after the disease sets in.

This could be because high blood sugar levels stiffen the lung tissue, or because the fat tissue in the chest and abdomen may confine the lungs more in people with diabetes, explained the researchers. They concluded the study with advice to clinicians to “pay heightened attention to pulmonary function in their patients with type 2 diabetes.”

“Think of the lung as a crime victim who unwittingly abets the perpetrator to hasten the demise of the host,” wrote Dr. Connie Hsia, of the University of Texas Southwestern Medical Center’s Department of Internal Medicine, in an editorial accompanying the study. She suggested that the loss of pulmonary function could add

to diabetic morbidity and mortality, and raised concerns about the potential use of inhaled insulin, since it may “trigger or exacerbate pulmonary dysfunction.”

Recently, makers of inhaled insulin have pulled their products from the market because of poor sales or halted product investigations, though several companies continue to explore this type of insulin delivery.

“Manufacturers of inhaled insulin should find these data useful as they study potential long-term effects of their product on lung function,” said Dr. Fred Brancati, one of the lead researchers on the study. “The results suggest that doctors and patients should keep an eye on the literature about diabetes and the lung down the road, since there’s a stronger connection than we previously thought.”

Consensus Statement Urges Greater Lipid Control

The ADA-American College of Cardiology (ACC) paper highlights a new consensus suggesting that, in people who exhibit cardiometabolic risk factors (such as insulin resistance, hypertension, overweight/obesity, or a family history of premature heart disease), a certain protein called apolipoprotein B (apo B) may better predict the risk of heart disease than LDL cholesterol levels, long used as one measurement of good heart health. A panel of diabetes and heart experts agreed that LDL (“bad”) cholesterol was still an important risk factor, but that after LDL cholesterol levels were brought under control, ApoB (a measure of the number of LDL particles in the blood that cause hardening of the arteries) should also be tested and treated to target levels in people at high risk.

The statement emphasizes the need to examine all factors for heart disease, to continue to focus on lifestyle interventions to reduce the risk for type 2 diabetes and heart disease, and to more aggressively control all lipids. The paper also urged health care providers to look at a person’s lifetime risk for heart disease, rather than just at short-term risks.

Diabetes Care, published by the American Diabetes Association, is the leading peer-reviewed journal of clinical research into the nation’s fifth leading cause of death by disease. Diabetes also is a leading cause of heart disease and stroke, as well as the leading cause of adult blindness, kidney failure, and non-traumatic amputations. For more information about diabetes, visit the American Diabetes Association Web site http://www.diabetes.org or call 1-800-DIABETES (1-800-342-2383).

Posted by dlife at 09:28 AM | Comments (2)

A Link Between Antidepressants and Type 2 Diabetes

March 25, 2008 (EurekAlert) - While analyzing data from Saskatchewan health databases, Lauren Brown, researcher with the U of A’s School of Public Health, found people with a history of depression had a 30 per cent increased risk of type 2 Diabetes.

Brown then studied the medical history of 2,400 people who were diagnosed with depression and were taking antidepressants to determine whether there was a clear correlation between that disease and type 2 Diabetes.

Brown divided the group into four categories: those who took antidepressants that were considered older therapies, patients who were using newer treatments, those using a combination of both an old and new treatments and people who were switching medications.

What she found was the risk of diabetes almost doubled for the patients who were using two types of therapies at the same time, tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). Brown says people are usually prescribed multiple medications “if they have severe depression or if they are having a problem finding the right therapy.”

Brown believes these results, and results of previous studies demonstrating an increased risk of type 2 diabetes in people with depression, emphasize the need for regular screening for type 2 diabetes in people with depression, particularly those taking more than one antidepressant. She also encourages diabetes and depression organizations to educate their members about this link.

Posted by dlife at 03:37 PM | Comments (5)

Previously Unrecognized Testosterone Deficiency Common in Men with Type 1 Diabetes

March 25, 2008 (Newswise) - Testosterone deficiency, previously recognized as common in men with type 2 diabetes, is also common in men with type 1 diabetes according to a new study accepted for publication in the Journal of Clinical Endocrinology & Metabolism (JCEM). These findings suggest that there is a direct link between insulin resistance and reduced testosterone levels in men.

“As testosterone deficiency may contribute to impaired performance, mood, and libido, as well as have adverse impact on cardiovascular risk, these findings demonstrate the presence of a significant and unrecognized problem among men with diabetes,” said Dr. Mathis Grossmann of the University of Melbourne in Australia. “Our findings of insulin resistance as a potential determinant of reduced testosterone levels may represent an important avenue for intervention.”

For this study, researchers conducted a survey of 580 men with type 2 diabetes and 69 men with type 1 diabetes. A subgroup of 262 men with type 2 diabetes was then reassessed after six months. Testosterone levels were measured from blood samples using the Access testosterone assay.

Previous population-studies found an association of reduced testosterone levels in men and type 2 diabetes, however this is the first study to demonstrate a similar prevalence in individuals with type 1 diabetes.

This study raises the question of whether testosterone replacement therapy can reduce insulin resistance or symptoms of hypogonadism in men with diabetes. Researchers, however stress that the balance of benefits and risks of such treatment is currently unknown and still to be defined by large and long-term clinical trials. Also, while insulin resistance is associated with testosterone deficiency, there is no evidence that insulin sensitizers are able to elevate testosterone levels in men with diabetes.

Other researchers working on the study include Merlin Thomas, Sianna Panagiotopoulos, Ken Sharpe, Richard MacIsaac, Sophie Clarke, Jeffrey Zajac, and George Jerums of the University of Melbourne in Australia.

A rapid release version of this paper has been published on-line and will appear in the May 2008 issue of JCEM, a publication of The Endocrine Society.

Founded in 1916, The Endocrine Society is the world’s oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society, and the field of endocrinology, visit our web site at http://www.endo-society.org.

Posted by dlife at 10:22 AM | Comments (0)

Scientists Link 11 Genetic Variations to Type 2 Diabetes

March 24, 2008 (Newswise) — Mathematicians at Michigan Technological University have developed powerful new tools for winnowing out the genes behind some of humanity’s most intractable diseases.

With one, they can cast back through generations to pinpoint the genes behind inherited illness. With another, they have isolated 11 variations within genes—called single nucleotide polymorphisms, SNPs or “snips”—associated with type 2 diabetes.

“With chronic, complex diseases like Parkinson’s, diabetes and ALS [Lou Gehrig’s disease], multiple genes are involved,” said Qiuying Sha, an assistant professor of mathematical sciences. “You need a powerful test.”

That test is the Ensemble Learning Approach (ELA), software that can detect a set of SNPs that jointly have a significant effect on a disease.

With complex inherited conditions, including type 2 diabetes, single genes may precipitate the disease on their own, while other genes cause disease when they act together. In the past, finding these gene-gene combinations has been especially unwieldy, because the calculations needed to match up suspect genes among the 500,000 or so in the human genome have been virtually impossible.

ELA sidesteps this problem, first by drastically narrowing the field of potentially dangerous genes, and second, by applying statistical methods to determine which SNPs act on their own and which act in combination. “We thought it was pretty cool,” Sha said.

To test their model on real data, Sha’s team analyzed genes from over 1,000 people in the United Kingdom, half with type 2 diabetes and half without. They identified 11 SNPs that, singly or in pairs, are linked to the disease with a high degree of probability. Their work has been accepted by the journal Genetic Epidemiology and is available online at http://www3.interscience.wiley.com/cgi-bin/abstract/117890704/ABSTRACT .

ELA is used to compare the genetic makeup of unrelated individuals to sort out disease-related genes. The team has also developed another approach, which uses a two-stage association test that incorporates founders’ phenotypes, called TTFP, that can examine the genomes of family members going back generations.

“In the past, researchers have dealt with the nuclear family, parents and children, but this could go back to grandparents, great-grandparents . . . as far back as you want.”

The team has published their findings in the European Journal of Human Genetics. An abstract is available at http://www.nature.com/ejhg/journal/v15/n11/abs/5201902a.html .

Now that they’ve developed the software, the analysis is relatively simple, says Sha. But getting the genetic data to work on is not. “We don’t have the data sets yet to work with,” she says, clearly frustrated. “That’s the problem with having no medical school.”

Those who do have data sets, however, can use the team’s software to help find the cause—and hopefully, the cures—for a panoply of illnesses. ELA is available in Windows and Linux versions at http://www.math.mtu.edu/~shuzhang/software.html, and TTFP is available by request.

Other members of Michigan Tech's statistical genetics group are Associate Professor Shuanglin Zhang and postdoctoral scientists Zhaogong Zhang and Tao Feng.

Posted by dlife at 09:42 AM | Comments (0)

NYU Dental Researchers Find Evidence of Periodontal Disease Leading to Gestational Diabetes

The findings, published in the April 2008 issue of the Journal of Dental Research, underscore how important it is for expectant mothers to maintain good oral health

March 24, 2008 (EurekAlert) - A study by a New York University dental research team has discovered evidence that pregnant women with periodontal (gum) disease are more likely to develop gestational diabetes mellitus than pregnant women with healthy gums.

The study, led by Dr. Ananda P. Dasanayake, a professor of epidemiology & health promotion at the NYU College of Dentistry, followed 256 women at New York’s Bellevue Hospital Center through their first six months of pregnancy. Twenty-two women developed gestational diabetes. Those women had significantly higher levels of periodontal bacteria and inflammation than the other women in the study.

The findings, published in the April 2008 issue of the Journal of Dental Research, underscore how important it is for expectant mothers to maintain good oral health.

“In addition to its potential role in preterm delivery, evidence that gum disease may also contribute to gestational diabetes suggests that women should see a dentist if they plan to get pregnant, and after becoming pregnant,” says Dasanayake. “Treating gum disease during pregnancy has been shown to be safe and effective in improving women’s oral health and minimizing potential risks.”

“In the future,” he added, “we can expect to see more research on the link between these two conditions involving other high risk groups, such as Asian and Native American women.”

Gestational diabetes is characterized by an inability to transport glucose -- the main source of fuel for the body -- to the cells during pregnancy. The condition usually disappears when the pregnancy ends, but women who have had gestational diabetes are at a greater risk of developing the most common form of diabetes, known as Type 2 diabetes, later in life. Hispanics, Asians, and Native Americans are at the highest risk for developing gestational diabetes. Eighty percent of the women in the NYU study were Hispanic.

Inflammation associated with periodontal disease is believed to play a role in the onset of gestational diabetes, perhaps by interfering with the normal functioning of insulin, the hormone that regulates glucose metabolism.

Posted by dlife at 09:16 AM | Comments (0)

Grape Skin Compound Fights The Complications Of Diabetes

March 20, 2008 (Science Daily) - Research carried out by scientists at the Peninsula Medical School in the South West of England has found that resveratrol, a compound present naturally in grape skin, can protect against the cellular damage to blood vessels caused by high production of glucose in diabetes, according to a recently published paper in the science journal "Diabetes, Obesity and Metabolism."

The elevated levels of glucose that circulate in the blood of patients with diabetes causes micro- and macrovascular complications by damaging mitochondria, the tiny power plants within cells responsible for generating energy. When they are damaged they can leak electrons and make highly damaging 'free radicals'.

Complications that can result when this happen include nephropathy (kidney disease), heart disease and retinopathy (which if left untreated can lead to blindness).

Resveratrol stops the damage by helping cells make protective enzymes to prevent the leakage of electrons and the production of toxic 'free radicals'.

As well as being naturally present in grape skins, resveratrol is also present in seeds, peanuts and red wine.

Dr. Matt Whiteman, Principal Investigator and Senior Lecturer at the Institute of Biomedical and Clinical Science, Peninsula Medical School, commented: "Resveratrol's antioxidant effects in the test tube are well documented but our research shows the link between high levels of glucose, its damaging effect on cell structure, and the ability of resveratrol of protect against and mend that damage."

He added: "Resveratrol or related compounds could be used to block the damaging effect of glucose which in turn might fight the often life threatening complications that accompany diabetes. It could well be the basis of effective diet-based therapies for the prevention of vascular damage caused by hyperglycaemia in the future."

Posted by dlife at 02:27 PM | Comments (14)

Joslin Researchers Discover New Effect For Insulin

March 20, 2008 (EurekAlert) - Researchers at the Joslin Diabetes Center have shown that insulin has a previously unknown effect that plays a role in aging and lifespan, a finding that could ultimately provide a mechanism for gene manipulations that could help people live longer and healthier lives.

The paper, published in the March 21st issue of Cell, reports that insulin inhibits a master gene regulator protein known as SKN-1, and that increased SKN-1 activity increases lifespan. SKN-1 controls what is called the Phase 2 detoxification pathway, a network of genes that defends cells and tissue against oxidative stress – damage caused by elevated levels of free radicals (byproducts of metabolism) – and various environmental toxins. The new finding was demonstrated in experiments on the digestive system of C. elegans, a microscopic worm often used as a model organism.

“We’ve found something new that insulin does and it has to be considered when we think about how insulin is affecting our cells and bodies,” said Dr. T. Keith Blackwell, senior investigator at Joslin and author of the paper. “This has implications for basic biology since under some circumstances insulin may reduce defense against the damaging effects of oxidative stress more than we realize.”

The idea down the line is that fine-tuning the activity of SKN-1 may lead to increased resistance to chronic diseases and influence longevity, he said. The work could be important as it relates to diabetes and the many problems associated with the disease, particularly vascular and renal complications.

But, today’s finding may be most important for what it teaches about aging in general, he said.

“The major implication is that we have found something new that affects lifespan and aging, and an important new effect that insulin and/or a related hormone called insulin-like growth factor-1 may have in some tissues,” said Blackwell. “The implications go far beyond diabetes.”

It has been known since the 1990s that insulin inhibits a gene regulator protein known as FOXO, important in diabetes metabolism, tumor suppression and stem cell maintenance. FOXO controls a number of genes, including many involved in stress resistance. Studies in C. elegans showed that reduced insulin signaling boosted activity of a FOXO protein known as DAF-16, leading to greater stress resistance and longer life.

The new work places SKN-1 alongside FOXO as a second master gene regulator that is inhibited by insulin signaling and adds to the body of knowledge about insulin and its effects on gene pathways, stress resistance and aging. According to the paper, insulin’s effect on SKN-1 occurs independently of its effect on DAF-16.

“You can manipulate the expression of SKN-1 and the worms live longer,” said Blackwell, an Associate Professor of Pathology at Harvard Medical School and faculty member at the Harvard Stem Cell Institute.

The experiments will have to be repeated in mammals, where insulin and insulin-like growth factor-1 have a complex array of effects in different tissues. But, according to Blackwell, other findings in the C. elegans model have generally turned out to be applicable to mice and humans.

Blackwell’s lab at Joslin is focusing on mechanisms of free radical resistance and aging, and on gene regulation mechanisms in C. elegans stem cells with the idea of using this knowledge towards reprogramming human stem cells into insulin-producing cells.

Posted by dlife at 11:52 AM | Comments (0)

Uric Acid May Provide Early Clues to Diabetic Kidney Disease

March 17, 2008 (Newswise) — For patients with type 1 diabetes, increased levels of uric acid in the blood may be an early sign of diabetic kidney disease—appearing before any significant change in urine albumin level, the standard screening test, reports a study in the May 2008 issue of the Clinical Journal of the American Society of Nephrology.

The results raise the possibility that treatments to reduce uric acid might slow the decline of renal function in patients with diabetes. "Thus we have the hope of having a means to thwart the loss of kidney function while function is still in a relatively preserved stage," comments Dr. Elizabeth T. Rosolowsky of Joslin Diabetes Center, Boston.

The researchers measured serum uric acid concentration in 675 patients with type 1 diabetes. On screening tests, 311 patients had small amounts of the protein albumin in the urine. This result—called microalbuminuria—is generally regarded as a harbinger of kidney function loss in diabetic kidney disease (nephropathy). The other 364 patients had normal urine albumin levels.

None of the patients had higher levels of albumin (albuminuria) representing more advanced diabetic nephropathy. Nevertheless, one in five had some impairment of kidney function on a standard test, the glomerular filtration rate. "Our research showed that loss of kidney function takes place even in the absence of albuminuria in patients with type 1 diabetes," says Dr. Rosolowsky.

In contrast, the serum uric acid level was consistently related to kidney function—the higher the uric acid, the lower the kidney function. "The serum concentration of uric acid in these patients varied in a manner consistent with its having played a role in this early loss of kidney function," according to Dr. Rosolowsky.

Urine albumin is commonly measured to identify patients with type 1 diabetes at risk of developing nephropathy. "Historically, it was believed that the start of kidney function loss happened only when the amount of leakage of albumin into the urine had reached a certain level," Dr. Rosolowsky explains. "However, recent studies by our group have suggested that kidney function loss may start much earlier in some patients with type 1 diabetes." Other studies have suggested that increased serum uric acid levels are associated with loss of kidney function, and may even be a causative factor.

If higher uric acid levels do contribute to loss of kidney function, then the findings may offer a new approach to treating diabetic kidney disease. "The serum uric acid concentration is modifiable by drugs or by decreasing the intake of dietary protein, the main source of uric acid," says Dr. Rosolowsky. "If follow-up studies, already underway, demonstrate that serum uric acid concentration predicts the course of early decline in kidney function, then clinical trials would be justified to test whether modifying serum uric acid concentration also modifies the course of renal function decline in type 1 diabetic patients with high normoalbuminuria or microalbuminuria."

The American Society of Nephrology (ASN) is a not-for-profit organization of 11,000 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. ASN publishes the Journal of the American Society of Nephrology (JASN), the Clinical Journal of the American Society of Nephrology (CJASN), and the Nephrology Self-Assessment Program (NephSAP).

Posted by dlife at 03:51 PM | Comments (0)

Blood Vessel Protein Reverses Macular Degeneration, Diabetic Retinopathy in Mice

March 16, 2008 (EurekAlert) - Two major eye diseases and leading causes of blindness—age-related macular degeneration and diabetic retinopathy—can be reversed or even prevented by drugs that activate a protein found in blood vessel cells, researchers at the University of Utah School of Medicine and several other institutions have announced in a new study.

Damage from both diseases was prevented and even reversed when the protein, Robo4, was activated in mice models that simulate age-related macular degeneration (AMD) and diabetic retinopathy, according to Dean Y. Li, M.D., Ph.D., senior author of the study published March 16 in Nature Medicine online.

Robo4 treated and prevented the diseases by inhibiting abnormal blood vessel growth and by stabilizing blood vessels to prevent leakage. Abnormal blood vessel growth and leakage are two primary factors in both age-related macular degeneration (AMD) and diabetic retinopathy. But the study’s ramifications go beyond eye diseases.

Serious infections such as SARS (Severe Acute Respiratory Syndrome), for example, kill people when an infection destabilizes blood vessels, allowing fluids to leak into the lungs. Tumors hijack blood vessel growth to feed on nutrients and grow. Although this study did not prove Robo4 would treat those diseases, Li believes it merits investigation.

“Many diseases are caused by injury or inflammation destabilizing blood vessels and causing them to leak fluid into adjacent tissues as well,” said Li, professor of internal medicine and an investigator with the University’s Program in Human Molecular Biology and Genetics. “We found a natural pathway – the Robo4 pathway – that counterattacks this by stabilizing blood vessels.”

“This discovery has significant implications for developing drugs that activate Robo4 to treat AMD and diabetic retinopathy,” said Kang Zhang, M.D., Ph.D., associate professor of ophthalmology and visual sciences at the University of Utah’s John A. Moran Eye Center and an investigator with the University’s Program in Human Molecular Biology and Genetics. Li and Zhang’s laboratories closely collaborated on the research, using the same animal models of AMD and diabetic retinopathy that are required for drug development. The collaboration means the time required to test the approach in people could be shortened, perhaps by years. Nonetheless, both Zhang and Li caution that getting new drugs to market still would take a number of years.

Randall J. Olson, M.D., director of the University’s John A. Moran Eye Center and professor and chair of ophthalmology and visual sciences, called Li’s finding historic.

“This is a major breakthrough in an area where the advances have been minimal,” Olson said. “We are excited about taking this opening and moving the frontier forward with real hope for patients who have but few, often disappointing, options.”

The discovery is a prime example of basic science research yielding a discovery with direct clinical applications, according to Hemin Chin, Ph.D., director of ocular genetics program at the National Eye Institute. “Given that vascular eye diseases, such as age related macular degeneration and diabetic retinopathy, are the number one cause of vision loss in the United States, the identification of new signaling pathways that prevent abnormal vessel growth and leakage in the eye represents a major scientific advancement,” said Chin.

Blood vessel growth (angiogenesis) is critical in human development and as a response to injury or disease. In earlier research, Li had shown that a family of proteins, netrins, induce blood vessel and nerve growth in mice, a discovery with important ramifications for potential therapies to help people with too few blood vessels. But when the body grows new blood vessels at the wrong time or place, these blood vessels are often unstable and weak, which causes them to leak and potentially lead to diseases such as macular degeneration and diabetic retinopathy.

In 2003, Li’s laboratory cloned Robo4 and showed it served the opposite function of netrins by inhibiting blood vessel growth and the destabilization that causes leakage. Robo4 is found only in cells in the interior surface of blood vessels and is activated by a protein called Slit. After being activated, Robo4 initiates a chain of biochemical events to stabilize blood vessels and prevent uncontrolled growth.

“Everything in biology has a yin (negative) and a yang (positive), and in the previous paper on netrins we brought attention to a new signaling pathway that induces vessels and nerves to grow,” Li said. “Robo4 is the yin to that process, preventing new vessel growth by stabilizing the integrity of mature blood vessels.”

Age-related macular degeneration is the most common cause of legal blindness in people age 65 or older and is expected to become an increasingly common and costly health issue as the number of older people in United States increases. Diabetic retinopathy is the most common cause of legal blindness in working-age Americans. Currently, there are an estimated 21 million people with diabetes.

Posted by dlife at 01:51 PM | Comments (6)

Minority, Low-Income Diabetics Least Likely to Monitor Their Blood Glucose

March 14, 2008 (EurekAlert) - Black and Hispanic adults with insulin-treated diabetes are less likely than whites to monitor their blood glucose, according to a new study presented at the American Heart Association’s 48th Annual Conference on Cardiovascular Disease Epidemiology and Prevention.

The disparities were greatest for low-income Hispanics, said Deborah A. Levine, M.D., M.P.H., lead author of the study.

“Minority and financially vulnerable adults with insulin-treated diabetes appear to have lower reported rates of self-monitoring of blood glucose (SMBG) — a vital disease management component,” said Levine, assistant professor in general internal medicine at the Ohio State University College of Medicine in Columbus.

“Efforts to improve diabetes control, including the collection and use of SMBG data in Hispanic and black populations with diabetes (particularly those on insulin), are warranted given that Hispanics and blacks have a higher frequency of diabetes-related complications compared to whites. We need to better understand income’s role in racial and ethnic disparities in SMBG to offer effective programs and policies to improve SMBG by minorities.”

In the study, Levine and colleagues focused on adults with insulin-treated diabetes, the group with the strongest evidence and recommendations for SMBG. Their analysis included recent data from a nationally representative, population-based survey, including 16,630 adults 19 years and older with insulin-treated diabetes.

Researchers examined SMBG at least daily among Hispanics, blacks and whites by annual household income of less than $20,000 versus $20,000 or more ($20,000 was the approximate federal poverty threshold for a family of two adults and two children in 2005).

They found that lower proportions of Hispanics and blacks reported daily SMBG than whites at every income level.

At incomes of $20,000 and higher, SMBG rates were:

* 78 percent for Hispanics

* 77 percent for blacks

* 85 percent for whites

Among those with incomes of less than $20,000, SMBG rates were:

* 65 percent for Hispanics

* 79 percent for blacks

* 85 percent for whites

In the income group of less than $20,000, 49 percent of Hispanics received diabetes education, versus 64 percent of blacks and 62 percent of whites.

“Receipt of diabetes education varied significantly by race/ethnicity only in the less-than-$20,000 income group,” Levine said. “At incomes of $20,000 or more, both Hispanics and blacks had 40 percent lower odds of daily SMBG compared to whites.

“At incomes of less than $20,000, however, the odds of daily SMBG decreased by 70 percent for Hispanics compared to whites, but did not change for blacks. Importantly, demographic characteristics, health insurance, health status and diabetes measures — including receipt of diabetes education, disease duration or end-organ damage — did not fully explain these racial and ethnic differences in SMBG.”

The findings suggest that although Hispanics and blacks performed SMBG less than whites, poverty significantly worsened disparities in SMBG and receipt of diabetes education among Hispanics, researchers said.

“Income must be explicitly considered when assessing SMBG performance and designing SMBG interventions for Hispanics with insulin-treated diabetes,” Levine said.

In 2005, 15.1 million adults 20 years and older (7.6 million males and 7.5 million females) had physician-diagnosed diabetes, according to the American Heart Association’s Heart Disease and Stroke Statistics – 2008 Update. This represents about 7.3 percent of the adult population. Non-Hispanic white males accounted for 6.7 percent of the cases and females accounted for 5.6 percent; non-Hispanic black males accounted for 10.7 percent and females accounted for 13.2 percent; Mexican-American males accounted for 11 percent and females accounted for 10.9 percent.

Posted by dlife at 01:54 PM | Comments (1)

MGH Initiates Phase I Diabetes Trial

March 14, 2008 (EurekAlert) - Scientists at the Massachusetts General Hospital (MGH) have initiated a phase 1 clinical trial to reverse type 1 diabetes. The trial is exploring whether the promising results from the laboratory of Denise Faustman, MD, PhD, can be applied in human diabetes. Faustman’s previous studies have shown that mice with a form of diabetes that closely resembles type 1 diabetes in humans can be cured. In the animal studies, a commonly used vaccine that provides protection against tuberculosis, called Bacillus Calmette-Guerin (BCG) was used effectively to deplete the abnormal immune cells that attack and destroy the insulin producing cells of the pancreas. The first step in the human study, which is currently enrolling volunteers, is to determine whether the same strategy using BCG vaccination can be used to modify the abnormal autoimmune cells that are present in type 1 diabetes, sometimes called “juvenile-onset” diabetes.

“We are pleased to be starting human clinical trials,” said Faustman. “Human trials take time, but we are making the step from curing diabetes in mice to determining whether it will work in men and women with diabetes.”

Type 1 diabetes usually starts during childhood or adolescence and can cause a variety of severe complications including kidney failure, loss of vision, amputations, heart disease, and strokes. It occurs when a person’s immune system attacks and destroys the insulin-producing cells in the pancreas. In the absence of insulin, which is necessary for sugar and other nutrients to enter cells, blood sugar levels rise. The risk for developing complications is closely linked to the elevated blood sugar levels over time. If blood sugar levels are well controlled, the long-term complications can largely be avoided. However, the so-called intensive therapy that is required to maintain near-normal sugar levels requires life-long demands on the patient, including frequent blood sugar monitoring and at least 3 daily injections of insulin or use of an insulin pump, along with restrictive diets. Insulin doses must be adjusted based on blood sugar levels, dietary factors, and anticipated exercise. Thus, a cure for diabetes has been highly sought after and has attracted much research interest.

The clinical trial is using the BCG vaccine for several reasons. BCG has been used safely for nearly 80 years as a tuberculosis vaccine. It is now being used in the human trial because it causes a low-grade inflammatory reaction, which in the mouse model of autoimmune diabetes lead to the destruction of the abnormal autoimmune cells.

David M. Nathan, MD, director of the MGH Diabetes Center, who is leading the human study at MGH, provides context, “This is the very first step in what is likely to be a long process in achieving a cure. We first need to determine whether the abnormal autoimmune cells that underlie type 1 diabetes can be knocked out with BCG vaccination, as occurred in the mouse studies.”

Posted by dlife at 10:24 AM | Comments (3)

Study in Circulation Research Details How Diabetes Drives Atherosclerosis

Mechanisms suggest new way to treat heart disease among diabetics

March 14, 2008 (EurekAlert) - Researchers have discovered how diabetes, by driving inflammation and slowing blood flow, dramatically accelerates atherosclerosis, according to research to be published in the March 14 edition of the journal Circulation Research.

Experts once believed that atherosclerosis, or hardening of the arteries, developed when too much cholesterol clogged arteries with fatty deposits called plaques. When blood vessels became completely blocked, heart attacks and strokes occurred. Today most agree that the reaction of the body's immune system to fatty build-up, more than the build-up itself, creates heart attack risk. Immune cells traveling with the blood mistake fatty deposits for intruders, akin to bacteria, home in on them, and attack. This causes inflammation that makes plaques more likely to swell, rupture and cut off blood flow.

Making matters worse, nearly 21 million Americans have diabetes, a disease where patients’ cells cannot efficiently take in dietary sugar, causing it to build up in the blood. In part because diabetes increases atherosclerosis-related inflammation, diabetic patients are twice as likely to have a heart attack or stroke.

Past work has shown that high blood sugar has two effects on cells lining blood vessels as part of atheroslerosis. First, it increases the production of free radicals, highly reactive molecules that tear about sensitive cell components like DNA, causing premature cell death (apoptosis). This process also reduces the availability of nitric oxide (NO), which would otherwise enable blood vessels to relax and blood flow to increase. In contrast to diabetes, exercise and good diet bring about faster blood flow through blood vessels. The force created by fast, steady blood flow as it drags along blood vessel walls has been shown by recent studies to protect arteries from atherosclerosis. Physical force has emerged recently as a key player in bodily function, capable of kicking off biochemical processes (e.g. weightlifting thickens bone).

“Inflammation is blood vessels is one of the main drivers of atherosclerosis, and diabetes makes it much worse,” said Jun-ichi Abe, M.D., Ph.D., associate professor with the Aab Cardiovascular Research Center at the University of Rochester Medical Center, and a study author. “Our study argues that a pathway surrounding a key signaling enzyme both protects the heart in normal cases, and is sabotaged by the chemicals produced in diabetes. We believe we have found a new therapeutic target for the treatment of diabetes-related damage to blood vessels.”

How Diabetes Does It

In people without diabetes, fast blood flow triggers an enzyme called extracellular signal-regulated kinase 5 (ERK-5). ERK5 in turn signals endothelial nitric oxide synthase (eNOS) to produce more nitric oxide and dilate blood vessels. It also activates Kruppel-like factor 2 (KLF2) and peroxisome proliferator-activated receptor-g (PPARg), both of which block the ability of pro-inflammatory immune cells to home in on and adhere to diseased portions of blood vessels.

Past studies had shown diabetes to worsen atherosclerosis, but its exact link to related inflammation had remained unclear. The current results provides the first mechanistic description of how diabetes takes away the ability of fast blood flow force to protect blood vessels, arguing that it does so by interfering with ERK5 and its signaling partners.

Abe’s team showed that molecules called advanced glycation end products (AGEs), produced in greater levels by patients with diabetes, interfere with ERK5 cardioprotection. Glycation reactions cause the release of oxidizing side products like hydrogen peroxide (H202) that drive free radical production, inflammation and cell damage in many diseases.

Researchers found that AGEs and H202 sabotage ERK5 by encouraging the attachment to it of a small ubiquitin-related modifier (SUMO), a protein tag used by cells to fine-tune their control over proteins. In normal function, a cell may extend a protein’s lifespan, or send it from one part of the cell to another, by attaching a SUMO tag. In the current study, researchers found that AGEs and H202 induced ERK5-SUMOylation as part of disease. In addition, the team found that ERK5-SUMOylation was increased in the aortas of diabetic mice.

Along with Abe, Chang-Hoon Woo, Tetsuro Shishido and Carolyn McClain contributed to the work within the Aab Cardiovascular Research Center. Jae Hyang Lim and Jian-Dong Li within the Department of Microbiology & Immunology at the Medical Center contributed expertise, along with Jay Yang, professor of Anesthesiology at Columbia University. This work is supported by grants from the America Heart Association and the National Institutes of Health.

“Our experiments found that taking away the “SUMO tag” from ERK protects blood vessels against diabetes,” Abe said. “We believe that the SUMOylation of ERK turns off ‘good’ genes that are important in countering atherosclerosis. In the next phase, we will be looking for drug candidates that can turn on ERK5 as diabetes attempts to shut it down.”

Posted by dlife at 10:18 AM | Comments (1)

Diabetes Ten City Challenge Collaborative Model

March 13, 2008 (PR Newswire) - Interim results show that participants in the Diabetes Ten
City Challenge (DTCC) improved across all key clinical and patient satisfaction indicators in the
early stages of the program, the American Pharmacists Association (APhA) Foundation
announced today.

Initial data show a positive trend in controlling diabetes, the chronic disease that affects 21 million
Americans and costs the U.S. more than $174 billion annually. The final DTCC report, due out in
2009, will include cost-savings data for DTCC employers.

The Diabetes Ten City Challenge (DTCC) is an employer-based diabetes self-management
program conducted by APhA Foundation with support from GlaxoSmithKline. Since it was
launched in October 2005, 31 employers in ten cities have joined forces with hundreds of
pharmacists to help more than 1,000 people manage their diabetes.

Through the DTCC, employers establish a voluntary health benefit for employees, dependents and
retirees with diabetes, and waive co-payments for diabetes medications and supplies if they work
with a pharmacist “coach” to manage their condition in collaboration with their doctors and diabetes
educators. The DTCC is modeled after other highly successful APhA programs that have proven
to improve overall health, reduce absenteeism, shorten hospital stays and reduce health care
costs.

“The results to date prove that this collaborative-practice model is effective for managing diabetes
and replicable in diverse locations and employers,” said William M. Ellis, CEO of the APhA
Foundation and co-author of a peer-reviewed article on the results published in the March/April
issue of the Journal of the American Pharmacists Association (JAPhA). “In years of experience
with this model we have seen that when you have positive clinical outcomes and increased patient
satisfaction in the early stages, the economic benefits follow.”

Key Findings

The report released today analyzed aggregate data on 914 DTCC participants who were in the
program at least three months as of September 30, 2007. It documented clinical improvements in
all the recognized standards for diabetes care, including:

• Decreases in laboratory measures (mean) for hemoglobin A1C (a laboratory test showing the
patient’s average blood sugar control over the previous two to three months), LDL cholesterol
and blood pressure over the initial year of the program
• Increases in the number of participants with current influenza vaccinations, foot examinations
and eye examinations
• 21% increase in the number of participants achieving the American Diabetes Association goal
of A1c level <7.0
• Increase from 43.8% to 57.7% in participants achieving nationally recognized National
Cholesterol Education Program goals for LDL cholesterol
• 15.7% increase in the number of people achieving recognized goals for systolic blood
pressure

Other Key Data

• The number of DTCC participants who felt their overall diabetes care was “very good to
excellent” increased from 39% to 87%
• More than 97% of participants reported being “very satisfied” or “satisfied” with diabetes care
provided by DTCC pharmacists
• The number of participants with self-management goals to control their diabetes also
increased significantly over the course of the program: the number of people with nutrition
goals increased from 22% to 66%; the number of people with weight goals increased from
23% to 64%; and the number of participants with exercise goals increased from 24% to 72%

“The data show significant improvement in all clinical and diabetes care indicators measured,” said
Toni Fera, PharmD, principal author of an article on the results appearing in the March/April issue
of the Journal of the American Pharmacists Association. “These results are consistent with data
from past projects where similar clinical improvements translated to annual savings to employers in
total direct medical costs for participants."

"Chronic diseases like diabetes are threatening the stability of our healthcare system," said
GlaxoSmithKline President of U.S. Pharmaceuticals, Chris Viehbacher. "By focusing on patients
and helping them to better understand and self-manage their condition, we can improve their
health and lower costs. GSK is proud to support the Diabetes Ten City Challenge because it is a
model that works and can be replicated.”

How the DTCC Model Works

The APhA Foundation contracts with employers, helps establish local pharmacist networks and
provides software and data analysis for the DTCC. Employers offer the voluntary employee benefit
and compensate pharmacists for the care provided. Participating pharmacists, who are specially
trained in diabetes care, educate participants on diabetes, diet and nutrition. These “pharmacist
coaches” meet with participants regularly to help them track key diabetes indicators and manage
their diabetes by eating right, exercising regularly, visiting their doctors and taking medications as
prescribed.

Physicians are informed of participants’ enrollment and are encouraged to share individual patient
care plans with the pharmacist, who reinforces those plans in personal meetings. Pharmacists
communicate with physicians after every visit and refer patients to other health care providers as
needed for additional care or education.

Expanding the DTCC Model for all Chronic Diseases

An additional 50 employers and 1,300 employees are using the DTCC model through the APhA
Foundation’s HealthMapRx™ to manage many chronic diseases, such as diabetes and
cardiovascular disease.

“The Diabetes Ten City Challenge provides an opportunity to transform health care delivery in
local communities and drive fundamental change in the U.S. health care system,” Ellis said. “Our
overall goal is to make this model as widely available as possible and encourage employers to
invest in helping their employees manage all chronic conditions. Our nation’s health care system
is broken – we need more programs that are an investment in wellness rather than an expense for
sickness.”

About the APhA Foundation (www.aphafoundation.org)

The American Pharmacists Association (APhA) Foundation, headquartered in Washington, D.C., is
a non-profit organization affiliated with the American Pharmacists Association, the national
professional society of pharmacists in the United States.

The APhA Foundation has expertise in designing programs that seek to create a new medication
use system in the U.S. where patients, pharmacists, physicians and other health care providers
collaborate to dramatically improve the cost and quality of consumer health outcomes through the
safe and effective use of medications.

Posted by dlife at 02:06 PM | Comments (0)

FDA Approves Abbott's FreeStyle Navigator(R) Continuous Glucose Monitoring System

New Tool Uniquely Provides Minute-by-Minute and Trend Information That Can Lead to Proactive Diabetes Management

March 13, 208 (PRNewswire-FirstCall) -- The Food and Drug Administration (FDA) has approved the FreeStyle Navigator(R) Continuous Glucose Monitoring System (http://www.continuousmonitor.com/) in the United States for people with diabetes.

Designed to discretely and continuously measure glucose levels through a sensor in the back of the upper arm or abdomen, Abbott's FreeStyle Navigator system provides minute-by-minute information about which way and how quickly blood sugar levels are changing. This information can lead to proactive adjustments that can result in tighter glucose ranges. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed.

The FreeStyle Navigator system will be available in the second quarter of 2008 by prescription only. It received CE Mark (http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0478 .htm) in June 2007 and has been available outside the United States since September 2007.

"Understanding glucose trends, with the goal of minimizing fluctuations, is an important part of improving the management of diabetes," said endocrinologist and Director of the International Diabetes Center Richard Bergenstal, M.D. "We are always looking for new tools like these to enable people with diabetes to continuously monitor their glucose levels, putting them on the offense, not defense, so they can take action before a high or low glucose level occurs."

For people with diabetes, less time spent with low (hypoglycemia) or high (hyperglycemia) blood sugar has been correlated with less risk for a number of serious short- and long-term diabetes-related complications.(1) By measuring glucose levels continuously, the FreeStyle Navigator system is designed to provide more and better information than traditional fingerstick glucose measurements, which can lead to improved diabetes management.

Abbott's FreeStyle Navigator system offers a number of key advances for people with diabetes who require insulin and want to tightly manage their disease. The system monitors glucose levels by measuring and transmitting glucose information once per minute to the pager-sized receiver, which can be clipped to a belt or carried in a pocket or purse. It also provides audible or vibrating alarms before glucose levels become too high or too low, displays five directional trend arrows to help people understand if glucose is rising or falling, and stores historical data and glucose trend information for up to 60 days. Additionally, the sensor and transmitter are designed to accommodate showering, swimming and a range of normal physical activities.

Clinical Trial Results

The accuracy, safety and efficacy of the FreeStyle Navigator system have been demonstrated in two separate pivotal clinical trials, including a five-day, in-clinic study and a study of people with type 1 and type 2 diabetes at home.

Five-Day In-Clinic Study(2): Abbott conducted a study to test the accuracy of its FreeStyle Navigator system in 58 subjects ranging in age from 18 to 64. This study met its primary endpoint of demonstrating accuracy over five days of wear. Using the Clarke Error Grid (CEG), comparing readings from a lab reference to a reading from the FreeStyle Navigator Continuous Glucose Monitoring System at a specific point in time, a combined 98.4 percent of the measurements were in the most accurate zones, A (81.7 percent) and B (16.7 percent), which means that measurements allowed patients to make either correct and safe treatment decisions, benign treatment decisions, or no treatment decision at all.

Home Use Study(3): In a study on the safety and efficacy of the FreeStyle Navigator system, 123 people with type 1 and type 2 diabetes used it in their homes for 40 days, wearing the sensor on the back of their upper arm or abdomen. Continuous glucose values were not visible to the user during the first half of the study, but were visible to the user during the second half of the study. A Clarke Error Grid (CEG) analysis demonstrated that 96.8 percent of the values were in the most accurate zones (zones A and B). Using a FreeStyle Navigator system, study participants with type 1 diabetes spent significantly less time in a hypoglycemic state (i.e., low blood sugar) -- a serious condition for this population -- during the phase of the trial when values were visible to the user. In addition, participants using a FreeStyle Navigator system who had type 2 diabetes spent significantly less time in a hyperglycemic state. Hyperglycemia (i.e., high blood sugar) is a serious problem, particularly for people with type 2 diabetes.

About the FreeStyle Navigator System

The FreeStyle Navigator system is composed of three parts: a sensor, a transmitter and a receiver. The sensor, worn for up to five days and then replaced, is placed just under the skin and is attached to a plastic sensor mount with adhesive to adhere to the skin, like a patch. The transmitter snaps into the sensor mount and sends glucose information wirelessly to the pager- sized receiver. The system discreetly measures glucose levels once per minute; provides high/low glucose alarms based on customizable, physician- and patient-determined levels; and delivers early-warning alarms that indicate if glucose levels are likely to be too high or too low 10, 20 or 30 minutes in advance. The system also stores up to 60 days worth of glucose information that can be analyzed by the user or a health care professional.

Indicated for people ages 18 and older, the FreeStyle Navigator system is designed to continually record interstitial fluid glucose levels for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator system are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed.

Additional information about the FreeStyle Navigator system is available at http://www.continuousmonitor.com.

About Abbott Diabetes Care

Abbott Diabetes Care, based in Alameda, Calif., is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help patients better manage their diabetes. Abbott Diabetes Care is committed to developing products to reduce the discomfort and inconvenience of blood glucose monitoring and introducing systems that are easier to use, require smaller blood samples and provide faster results.

Abbott Diabetes Care markets several leading-edge glucose monitoring systems and test strips in the United States for use in both home and hospital settings; leading brands include FreeStyle(R) Lite, FreeStyle Freedom(TM), FreeStyle Flash(R) and Precision Xtra.(TM) Additional information about Abbott Diabetes Care may be found at http://www.abbottdiabetescare.com.

Posted by dlife at 01:03 PM | Comments (6)

Extra vitamin D in Early Childhood Cuts Adult Diabetes Risk

Vitamin D supplementation in early childhood and risk of type 1 diabetes: a systematic review and meta-analysis

March 13, 2008 (EurekAlert) - Vitamin D supplements in early childhood may ward off the development of type 1 diabetes in later life, reveals a research review published ahead of print in the Archives of Disease in Childhood.

Type 1 diabetes is an autoimmune disorder, in which insulin producing beta cells in the pancreas are destroyed by the body’s own immune system, starting in early infancy. The disease is most common among people of European descent, with around 2 million Europeans and North Americans affected.

Its incidence is rising at roughly 3% a year, and it is estimated that new cases will have risen 40% between 2000 and 2010.

A trawl of published evidence on vitamin D supplementation in children produced five suitable studies, the pooled data from which were re-analysed.

The results showed that children given additional vitamin D were around 30% less likely to develop type 1 diabetes compared with those not given the supplement.

And the higher and the more regular the dose, the lower was the likelihood of developing the disease, the evidence suggested.

Levels of vitamin D, and sunlight, from which the body manufactures the vitamin, have been implicated in the risks of developing various autoimmune disorders, including multiple sclerosis and rheumatoid arthritis.

And there is a striking difference in the incidence of type 1 diabetes according to latitude and levels of sunlight exposure, with a child in Finland 400 times more likely to develop the disease than a child in Venezuela, say the authors.

Further evidence of vitamin D’s role comes from the fact that pancreatic beta cells and immune cells carry receptors or docking bays for the active forms of the vitamin.

Posted by dlife at 10:16 AM | Comments (1)

Weight Loss More Effective Than Intensive Insulin Therapy for Type 2 Diabetics

March 11, 2008 (EurekAlert) – Weight-loss and major lifestyle changes may be more effective than intensive insulin therapy for overweight patients with poorly controlled, insulin-resistant type 2 diabetes, according to a diabetes researcher at UT Southwestern Medical Center.

The National Heart, Lung, and Blood Institute of the National Institutes of Health recently halted part of an ongoing clinical trial on diabetes and heart disease after more than 250 people died while receiving intense treatment to drive their blood glucose levels below current clinical guidelines.

The evidence is compelling that when insulin levels are high, certain tissues are overloaded with fatty molecules, which leads to insulin resistance. And yet, the high blood glucose levels of many obese patients with insulin-resistant type 2 diabetes are being treated with increasing amounts of insulin in an attempt to overpower that resistance. While high doses of insulin may lower glucose levels, it will also increase the fatty molecules and may cause organ damage.

In a commentary in the March 12 issue of The Journal of the American Medical Association, Dr. Roger Unger, professor of internal medicine, wrote about the recent findings of his own and other labs that link insulin resistance to excess accumulation of fatty molecules in liver and muscle.

Dr. Unger, who has investigated diabetes, obesity and insulin resistance for more than 50 years said intensive insulin therapy is contraindicated for obese patients with insulin-resistant type 2 diabetes because it increases the fatty acids that cause diabetes. Instead, the most rational therapy eliminates excess calories, thereby reducing the amount of insulin in the blood and the synthesis of the fatty acids stimulated by the high insulin. Giving more insulin simply increases body fat.

“Evolution was unprepared for the change in the American diet to processed fast food and drive-through lanes,” he said. “There’s no way that our genes could evolve to gird themselves against the superabundance of very, very high-calorie foods that have flooded the U.S.”

Before the discovery of insulin, starvation was the only treatment for diabetes, said Dr. Unger, who is a member of the National Academy of Sciences.

“Today there are many treatment options, including bariatric surgery, if necessary, to lower the fat content in the body before you start giving insulin,” he said. “The fat is causing insulin resistance and killing the insulin-producing beta cells in the pancreas – that is what is causing type 2 diabetes.”

Giving more insulin simply channels the glucose into fat production. There is now a spectrum of therapies that improve diabetes by correcting the insulin resistance by reducing the body fat. Insulin treatment would be indicated only if all these fail.

Dr. Unger said insulin should be given to patients with insulin deficiency, but not if the insulin levels are already very high but ineffective. “Giving more insulin to an insulin-resistant patient is akin to raising the blood pressure of a patient with high blood pressure to overcome resistance to blood flow. Instead, you would try to reduce the resistance,” he said.

In the commentary, Dr. Unger said the increase in the number of patients with insulin-resistant type 2 diabetes can be traced to the epidemic of obesity that began in the U.S. after World War II, when food preparation was moved from the family kitchen to factories and companies that produce high-fat, calorie-dense foods, leading both men and women to consume substantially more calories on a daily basis. In addition, technological advancements such as televisions, computers and automobiles reduced the number of calories burned per day.

Type 2 diabetes occurs when the body is unable to make enough of the hormone insulin to compensate for insulin resistance. The condition affects between 18 million and 20 million people in the U.S.

Factors that increase the risk of type 2 diabetes include obesity, age and lack of exercise. Over a period of years, high blood sugar damages nerves and blood vessels, leading to complications such as heart disease, stroke, blindness and kidney disease.

Posted by dlife at 10:23 AM | Comments (4)

Smiths Medical MD, Inc. Issued a Voluntary Recall of Specific Serial Numbers of the Deltec Cozmo® Insulin Pump

March 10, 2008 (Cozmo) - Smiths Medical MD, Inc. today issued a voluntary recall of specific serial numbers (see below) of the Deltec Cozmo® Insulin Pump.

Only 1023 recently manufactured pumps have been affected by this recall. These pumps were manufactured between November 2007 and January 2008. We have only been notified of 2 occurrences by customers, none of which have required any medical intervention

The reason for this recall is that the pumps may have an issue that affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user. Smiths Medical will be replacing all affected pumps.

After conducting a thorough investigation, Smiths Medical has concluded that the root cause of the motor issue was a manufacturing error with its component supplier. Through process control and process validation, this issue has now been corrected.

We will be notifying customers by mailing the recall letter via regular US Post and by telephoning customers. The Food and Drug Administration (FDA) has been informed of this action.

Any customer inquires related to this action should be addressed to Smiths Medical's customer service center at 1-800-826-9703.

Serial numbers for affected Deltec Cozmo® Insulin Pumps can be found here.

Posted by dlife at 03:18 PM | Comments (1)

More Kids with Diabetes, Few Specialized Docs to Care for Them

March 10, 2008 (Newswise) - The rate of childhood obesity in the United States has more than doubled in the past 20 years, bringing with it more children at risk for developing type 1 and even type 2 diabetes.

Despite this growing trend, the number of board-certified pediatric endocrinologists – those physicians who specialize in caring for children with diabetes and obese children at risk for the disease – is not keeping pace with demand for their specialized care, say researchers at the University of Michigan C.S. Mott Children’s Hospital.

Results from a new study published in the March issue of The Journal of Pediatrics show that at the national level, for every 290 children with diabetes, there is only one board-certified pediatric endocrinologist available to care for them. It also finds that the ratio of obese children to board-certified pediatric endocrinologists is about 17,000 to one.

“Although the American Diabetes Association recommends that all children with diabetes be cared for by a pediatric endocrinologist as part of a diabetes team, there is a current shortage of pediatric endocrinologists in this country,” says study lead author Joyce Lee, M.D., MPH, a pediatric endocrinologist and member of the Child Health Evaluation and Research (CHEAR) Unit in the U-M Division of General Pediatrics. “This problem will likely only worsen due to the recent epidemic of childhood obesity.”

Currently, 16.5 percent of American children ages 6 to 19 are obese. These children are at an increased risk for developing diseases previously thought to be limited to adults, including type 2 diabetes, high blood pressure and high cholesterol. As a result, more children than ever before are being referred to pediatric specialists, such as pediatric endocrinologists who can screen, evaluate and manage children at risk for developing diabetes.

“Even if just a small fraction of obese children are referred to a pediatric endocrinologist for evaluation, the overall ratio of one pediatric endocrinologist to 17,000 obese children makes providing the necessary care extremely challenging,” says Lee, assistant professor in the Department of Pediatrics and Communicable Diseases at the U-M Medical School.

The bottom line: pediatric endocrinologists currently do not have the capabilities to see even a fraction of the large number of children with diabetes or at risk for diabetes. “The epidemic of childhood obesity has undoubtedly created new challenges for our health care, and we need to reassess the current system to ensure children with diabetes or at risk for diabetes receive appropriate care,” Lee notes.

Using data from the American Board of Pediatrics and the National Survey of Children’s Health, Lee and her colleagues compared the number of board certified pediatric endocrinologists by region to obese children and children with diabetes in those same areas.

Their research revealed that there are an estimated 229,249 children with diabetes, and only 790 board-certified pediatric endocrinologists in the country. And, in two states – Montana and Wyoming – there are no board-certified pediatric endocrinologists.

Further complicating matters, Lee and her colleagues found that the geographic distribution of children with diabetes and obesity does not match the geographic distribution of board-certified pediatric endocrinologists.

According to study results, the area with the greatest supply of pediatric endocrinologists was in the Northeast. In comparison, the Midwest fared the worst with regard to the supply of pediatric endocrinologists. The geographic disparity was even greater for ratios of children with obesity to board-certified pediatric endocrinologists by state, ranging from about 5,000 to one in Massachusetts to about 99,000 to one in Mississippi.

While the American Board of Pediatrics reports that the number of medical fellows entering the field of pediatric endocrinology since 1997 has increased annually by 12 percent – with about 76 pediatricians entering the field from 2005 to 2006 – Lee cautions that it is still not enough of an increase to meet growing demand for care.

“The increases in the endocrinology workforce are incremental. Ultimately, the pediatric endocrine workforce shortage raises the question of how health care delivery for U.S. children with diabetes and children at risk for diabetes should ideally be organized,” says Lee.

She notes that a critical reassessment of the current system of health care delivery for obese children is needed, along with the creation of sustainable models of care to effectively improve health outcomes for obese children who are at risk for developing chronic diseases in childhood.

To learn more about childhood obesity and diabetes care offered at C.S. Mott Children’s Hospital, visit these Web sites:

• Pediatric endocrinology, diabetes and metabolism services: http://www2.med.umich.edu/departments/mott/clinics/dsp_cliniclist.cfm?group_id=ENDO
• Pediatric Comprehensive Weight Management Center: http://www.med.umich.edu/MPOWER/index.shtml

In addition to Lee, U-M C.S. Mott Children’s Hospital co-authors are: Matthew M. Davis, M.D., M.A.P.P., associate professor of general pediatrics and internal medicine, and associate professor of public policy at the Gerald R. Ford School of Public Policy; Ram K. Menon, M.D., professor, Department of Pediatrics and Communicable Diseases, and director of Pediatric Endocrinology; and Gary L. Freed, M.D., MPH, Percy and Mary Murphy Professor of Pediatrics and Child Health Delivery, and chief of the Division of General Pediatrics.

Lee’s work on this study was supported by the Clinical Sciences Scholars Program at the University of Michigan.

Reference: The Journal of Pediatrics, March 2008, Vol. 152, No. 3.

Posted by dlife at 03:06 PM | Comments (1)

Low Levels of PYY Hormone a Very Early Indicator of Type 2 Diabetes

March 10, 2008 (EurekAlert) - It may soon be possible to take a simple blood test and predict whether or not someone has low levels of a particular molecule, predisposing them to the development of Type 2 diabetes. If the test is positive, it may then be possible to use preventative treatment, slowing down, or even halting that development.

Such is the hope of scientists and clinicians at Sydney’s Garvan Institute of Medical Research who have shown conclusively that people who produce low levels of the molecule PYY have a higher risk of developing Type 2 diabetes and obesity.

The findings were published online on 4 March in the prestigious International Journal of Obesity.

It is already known that the hormone PYY, which is released from the gut after a meal, creates a feeling of satiety. When PYY is in oversupply, it prevents diet-in