Insulin Grown in Plants Relieves Diabetes in Mice; UCF Study Holds Promise for Humans

Henry Daniell's results and prior research indicate that insulin capsules could someday be used to prevent diabetes before symptoms appear and treat the disease in its later stages

July 31, 2007 (EurekAlert) - Capsules of insulin produced in genetically modified lettuce could hold the key to restoring the body’s ability to produce insulin and help millions of Americans who suffer from insulin-dependent diabetes, according to University of Central Florida biomedical researchers.

Professor Henry Daniell’s research team genetically engineered tobacco plants with the insulin gene and then administered freeze-dried plant cells to five-week-old diabetic mice as a powder for eight weeks. By the end of the study, the diabetic mice had normal blood and urine sugar levels, and their cells were producing normal levels of insulin.

Those results and prior research indicate that insulin capsules could someday be used to prevent diabetes before symptoms appear and treat the disease in its later stages, Daniell said. He has since proposed using lettuce instead of tobacco to produce the insulin because that crop can be produced cheaply and avoids the negative stigma associated with tobacco.

The National Institutes of Health provided $2 million to fund the UCF study. The findings are reported in the July issue of Plant Biotechnology Journal.

Insulin-dependent, or Type 1, diabetes is an autoimmune disease in which the body’s immune system attacks and destroys insulin and insulin-producing beta cells in the pancreas. Insulin is a hormone that is needed to convert sugar, starches and other food into energy.

Insulin typically is given through shots and not pills so the hormone can go straight into the bloodstream. In Daniell’s method, plant cell walls made of cellulose initially prevent insulin from degrading. When the plant cells containing insulin reach the intestine, bacteria living there begin to slowly break down the cell walls and gradually release insulin into the bloodstream.

“Currently, the only relief for diabetes is a momentary relief,” Daniell said. “Diabetics still have to monitor their blood and urine sugar levels. They have to inject themselves with insulin several times a day. Having a permanent solution for this, I’m sure, would be pretty exciting.”

Though produced in lettuce, the insulin would be delivered to human patients as a powder in capsules because the dosage must be controlled carefully.

If human trials are successful, the impact of Daniell’s research could affect millions of diabetics worldwide and dramatically reduce the costs of fighting a disease that can lead to heart and kidney diseases and blindness.

About 20.8 million children and adults in the United States, or about 7 percent of the population, have Type 1 or 2 diabetes, according to the American Diabetes Association.

The number of Americans with diabetes is projected to double by 2025, according to a study released last month by the National Changing Diabetes Program during a congressional briefing. That study by Mathematica Policy Research Inc. also reported that one of every eight federal health care dollars – $79.7 billion out of $645 billion -- is spent on treating people with diabetes.

“Diabetes is a big health and financial burden in the United States and in the rest of the world,” Daniell said. “This study would facilitate a dramatic change because so far there is no medicine that will cure insulin-dependent diabetes.”

Daniell’s method of growing insulin in plants is similar to what he used for an earlier study to produce anthrax vaccine in tobacco. In the earlier study, which also involved mice, Daniell showed and the National Institutes of Health confirmed that enough safe anthrax vaccine to inoculate everyone in the United States could be grown inexpensively in only one acre of tobacco plants

Posted by dlifenews at 10:08 AM | Comments (1)

Diabetes Drugs Increase Risk of Heart Failure, Research Shows

July 30, 2007 (EurekAlert) – A class of drugs commonly used to treat type 2 diabetes may double the risk of heart failure, according to a new analysis by researchers at Wake Forest University School of Medicine and colleagues.

Based on a review of research studies and case reports involving more than 78,000 patients, the authors concluded that the risk of heart failure may be up to 100 percent higher (depending on the type of study) in patients taking thiazolinediones (which includes Avandia® and Actos®). These drugs are known to enhance insulin sensitivity. The authors estimated that one additional patient with type 2 diabetes would develop heart failure for every 50 patients taking the drugs over a 26-month period.

The results were published online in May 2007 by Diabetes Care and will appear in the August print issue.
“These drugs are currently used by more than 3 million diabetic patients in the U.S. alone, suggesting that several thousand could be harmed,” said Sonal Singh, M.D., lead author and an assistant professor in internal medicine at Wake Forest.

Earlier this year, one of the drugs in this class (Avandia®) was linked to an increased risk of heart attack and death from cardiovascular causes.

The current analysis looked at a potential link between the drugs and heart failure, which is the inability of the heart to meet the body’s demands. Heart failure is a very common condition in the elderly and one of the costliest to society. Common symptoms include shortness of breath and the inability to exercise including, in some cases, even to walk short distances.

The authors hypothesize that fluid retention caused by the drugs may trigger heart failure in susceptible people.

Heart failure occurred equally at high and low doses. In fact, heart failure even occurred in some patients who were taking doses below those commonly prescribed. The medium time for the onset of heart failure was 24 weeks after beginning drug therapy.

The adverse reaction was not limited to the elderly – one-quarter of cases occurred in people younger than 60. Heart failure occurred equally among men and women.

The product label for both drugs warns against their use in patients with more severe cases of heart failure. The label also cautions about the increased risk of heart failure if used in combination with insulin. However, the current analysis found that the risk wasn’t confined just to patients on insulin, and it occurred even among patients without any risk factors for heart failure. “Our findings support current efforts by the FDA to add a black box warning to the labeling for those agents,” said co-investigator Curt Furberg, M.D., Ph.D., from Wake Forest.

“The occurrence of heart failure several months after initiation of treatment suggests a long-term effect of the drugs, which may not be avoided by beginning with low doses,” said Singh.

The authors called for additional research to evaluate whether there are differences between drugs in the class and how to best manage patients who experience heart failure while on the drugs.

Posted by dlifenews at 09:33 AM | Comments (3)

New Technique to 'See' and Protect Transplants Successful in Diabetic Animal Model

July 30, 2007 (EurekAlert) - Researchers at Johns Hopkins have found a way to overcome a major stumbling block to developing successful insulin-cell transplants for people with type I diabetes.

Traditional transplant of the cells, accompanied by necessary immune-suppressing drugs, has had highly variable results, from well- to poorly tolerated. Part of the problem, the Hopkins researchers say, is an inability to track the cells—so-called pancreatic beta cells—once they’re inside the body.

Now a new technique encapsulates the insulin-producing cells in magnetic capsules, using an FDA-approved iron compound with an off-label use, which can be tracked by magnetic resonance imaging (MRI). The product, tested in swine and diabetic mice, also simultaneously avoids rejection by the immune system, likely a major reason for transplant failure. The work will be published online next week in Nature Medicine.

“We’re really excited because we can track where we put the cells and make sure their protective housing stays intact and that the cells don’t move. This could solve the mystery of why current transplantation techniques work only for so long,” says one of the study’s authors, Aravind Arepally, M.D., assistant professor of radiology and surgery at Hopkins.

Type I diabetes—the most common childhood sort—causes a person’s immune system to destroy the pancreatic beta cells that make insulin. Without insulin, blood sugar levels can become dangerously high and lead to complications that include blindness or kidney failure. Careful monitoring of blood sugar levels paired with insulin injections can manage the condition, but transplanting healthy beta cells holds more promise for the moment-to-moment fine-tuning of insulin levels, says Arepally.

Current experimental cell transplantation techniques are done “naked and blind,” only lasting a short period of time, according to co-author Jeff Bulte, Ph.D., a professor of radiology and chemical and biomolecular engineering at Hopkins. The unprotected transplanted cells are vulnerable to attack by the recipient’s immune system, and researchers cannot see the cells to figure out why they stop making insulin after a while.

To address both of these challenges, the research team captured beta cells in tiny porous capsules made from a mixture of alginate, a gooey material made from seaweed, and Feridex, a magnetic iron-containing material visible under MRI. They then used a machine that oozes droplets of this mixture to surround and encapsulate individual islet clusters each containing about 500 to 1,000 insulin-producing beta cells. Once the cells are encapsulated, the shell hardens, creating a “magnetocapsule” that measures less than 1/128 of an inch across.

“They’re tiny spheres with nano-scale pores just big enough too let the good stuff out but keep the bad from getting in,” says lead author Brad Barnett, medical student and Howard Hughes fellow at Hopkins. The openings in the magnetocapsule are so small that the body’s immune system sentinels cannot reach and attack the transplanted cells.

The team first transplanted magnetocapsules into the abdomens of mice engineered to develop diabetes. Blood sugar levels in the animals returned to normal within a week and stayed that way for more than two months. In contrast, more than half of untransplanted diabetic mice died, and the rest had very high blood sugar levels.

To mimic human transplantation, the researchers then implanted magnetocapsules into the livers of swine with the help of MRI fluoroscopy, special reflective screens and a computer monitor that provide real-time imaging. The liver was chosen, rather than the usual pancreatic home of beta cells, because it contains many blood vessels that can deliver insulin quickly to the rest of the body.

“Getting the magnetocapsules into the right place requires hand-eye coordination normally required when playing video games,” says Arepally. The team threaded a long needle-like tube into a large vein near the upper thigh and guided the tube upward, across and into a neighboring blood vessel, ending in the body of the liver.

The pigs underwent MRI and blood tests three weeks after magnetocapsule transplantation. MRI showed that the magnetocapsules remained intact in the liver, and blood tests revealed that the cells were still secreting insulin at levels considered functional in people.

“We hope that our magnetocapsules will make tissue-type matching and immunosuppressive drugs problems of the past when it comes to cell-based therapies for type 1 diabetes,” says Bulte.

Posted by dlifenews at 09:29 AM | Comments (0)

¡GI Caramba! BlueTortillas May Help Dieters and Diabetics

July 30, 2007 (EurekAlert) - People with dieting blues should try swapping white corn tortillas for blue. A recent study suggests that the coloured flatbreads are healthier, especially for diabetics and dieters, Sara Jensen reports in Chemistry & Industry, the magazine of the SCI.

Scientists in Mexico, home of the taco, found that tortillas made from blue corn had less starch and a lower glycæmic index than their white counter parts. They also found that the blue tortillas had 20% more protein than white (Journal of the Science of Food and Agriculture, DOI 10.1002/jsfa.3008).

The glycæmic index (GI) ranks carbohydrates according to their effects on blood glucose levels. Foods with a lower GI are considered healthier as they slowly release sugar into the bloodstream. This reduces fluctuations in our blood glucose and insulin levels, helping to maintain a steady supply of energy. Low GI foods are said to have long-term health benefits, reducing your risk of heart disease and diabetes as well as aiding and maintaining weight loss.

Juscelino Tovar, an author of the study, said that one important benefit of the lower GI blue tortillas is their potential role in preventing or controlling metabolic syndrome, a combination of disorders which increase the risk of heart disease, stroke and diabetes.

NB The blue colouring is due to the presence of anthocyanins in the corn. These are the same health promoting compounds found purple berries and red wine.

Posted by dlifenews at 09:26 AM | Comments (0)

New Diabetes Report Documents Devastating Effects in New York City

Hospital costs have doubled since 1990

July 25, 2007 (EurekAlert) - The diabetes epidemic is taking a large and growing toll on New York City, a new Health Department report shows, as death rates, debilitating complications, and hospitalization costs soar. Some 500,000 New Yorkers – one out of eight adults – have been diagnosed with diabetes. Another 200,000 have diabetes but don’t yet know it. The death rate from diabetes rose by 75% between 1990 and 2003.

The new publication, which synthesizes research findings from the past several years, is available at www.nyc.gov/health. In addition to charting the impact of diabetes in NYC, it exposes unacceptable disparities among neighborhoods and racial/ethnic groups.

• New Yorkers in East Harlem, Williamsburg-Bushwick and certain parts of the South Bronx are hospitalized for diabetes at 10 times the rate of people living on the Upper East Side.

• Residents in the most affected areas also die from diabetes at seven times the rate of New Yorkers in the least affected neighborhoods.

• Among racial/ethnic groups, black New Yorkers have the highest death rate from diabetes, dying at three times the rate of white New Yorkers.

“Diabetes is hitting the city hard,” said Dr. Thomas R. Frieden, New York City Health Commissioner. “Tragically, it is hurting our low-income communities much more than others. With good management, we can prevent devastating complications of diabetes, such as heart disease, blindness, leg amputations and kidney failure.”

New Yorkers with diabetes are now hospitalized at a rate nearly 80% higher than the national rate. And the cost of these hospitalizations has skyrocketed in recent years, hitting $481 million in 2003, up from $242 million in 1990. Figures drawn from national estimates of total diabetes costs, including lost productivity and other non-medical costs, suggest that the economic impact of diabetes in New York City exceeds $6 billion annually.

“Diabetes is not only hurting our health, it’s hurting our wallets,” said Frieden. “The cost of treating diabetes is an unsustainable burden on our health system and economy. But even worse, behind these statistics are tragic individual stories that challenge our city and our health system to respond.”

Diabetes Management is Key
Many diabetes hospitalizations and deaths can be prevented by better management of the disease. Dr. Shadi Chamany, director of the Health Department’s Diabetes Prevention and Control program, emphasized that people with diabetes can live long and healthy lives if they carefully manage their blood sugar (an A1C level of less than 7%), blood pressure (less than 130 over 80) and bad cholesterol (LDL level below 100 mg/dL).

While most New Yorkers with diabetes are accessing health care, the report finds that both patients and providers could do much better. Among New Yorkers with diabetes:

• Most had a check-up in the past year, but more than one third did not receive an eye or foot exam.

• About 80% had their blood sugar tested in the past year, but only 16% knew their blood sugar level.

• About 45% had poor control of blood sugar, putting them at risk of serious health complications.

• One in five New Yorkers with diabetes is a smoker

Tracking Diabetes
The Health Department monitors blood sugar control citywide by requiring clinical laboratories to report blood sugar (A1C) test results to a central registry. This registry – the first of its kind in the nation – will enable the Health Department to give clinicians and patients feedback and resources that can improve the quality of care and quality of life for New Yorkers with diabetes.

The New York City Health and Nutrition Examination Survey, conducted by the Health Department in 2004, provided the first-ever estimates on diabetes prevalence and blood sugar control by using interviews, blood tests, and medical exams. This survey provided baseline data for tracking diabetes over time.

Other Initiatives

• The Department's Primary Care Information Project is working to improve health outcomes by helping primary care providers adopt electronic health records that make it easier to track and manage diabetes and other chronic conditions. The first phase of this initiative is now under way in the South Bronx, where the Health Department is working with providers who care for low-income patients.

• The Diabetes Public Health Detailing Campaign, completed in 2006, engaged more than 5,000 primary health care providers citywide to improve care and treatment of people with diabetes.

• The Diabetes Quality Improvement Collaborative works with clinics and hospitals in the City's highest-risk neighborhoods to improve care for people with diabetes.

• The Department has also launched programs to promote physical activity as part of a healthy lifestyle. SPARK is a training initiative for daycare and school staff to incorporate physical activity into education. Shape Up New York is a free family fitness program offered at parks, community centers and housing sites around the City.

• The Department also promotes healthy eating through the Healthy Bodegas Initiative and the Health Bucks program, aimed at increasing the accessibility of healthy food in the city.

Data Sources
The report drew upon numerous city and state data sources. Data on risk factors and health care indicators came from the New York City Community Health Survey (CHS), an annual telephone survey of 10,000 New York City adults. The survey derives health information from self-report.

Diabetes prevalence was assessed in the New York City Health and Nutrition Examination Survey (NYC-HANES) using a one-time blood test.

Hospitalization data come from the Statewide Planning and Research Cooperative System (SPARCS; New York State Department of Health, 2006) and consists of hospital discharge records for acute care hospitals in New York State.

Data were also complied from the 2000 Census, Medicare, and Medicaid records. A complete list of sources is available at the conclusion of the report.

Posted by dlifenews at 09:31 AM | Comments (0)

Diet and Regular Soft Drinks Linked to Increase in Risk Factors for Heart Disease

July 24, 2007 (American Heart Association) — Drinking more than one soft drink daily — whether it’s regular or diet — may be associated with an increase in the risk factors for heart disease, Framingham researchers reported in Circulation: Journal of the American Heart Association.

“We were struck by the fact that it didn’t matter whether it was a diet or regular soda that participants consumed, the association with increased risk was present,” said Ramachandran Vasan, M.D., senior author of the Framingham Heart Study and professor of medicine at Boston University School of Medicine. “In those who drink one or more soft drinks daily, there was an association of an increased risk of developing the metabolic syndrome.”

Metabolic syndrome is a cluster of cardiovascular disease and diabetes risk factors including excess waist circumference, high blood pressure, elevated triglycerides, low levels of high-density lipoprotein (HDL “good” cholesterol) and high fasting glucose levels. The presence of three or more of the factors increases a person’s risk of developing diabetes and cardiovascular disease.

Prior studies linked soft drink consumption to multiple risk factors for heart disease. However, this study showed that association not only included drinking regular calorie-laden soft drinks, but artificially sweetened diet sodas as well, researchers said.

“Moderation in anything is the key,” said Ravi Dhingra, M.D., lead author of the study and an instructor in medicine at Harvard Medical School. “If you are drinking one or more soft drinks a day, you may be increasing your risk of developing metabolic risk factors for heart disease.”

The Framingham study included nearly 9,000 person observations made in middle-aged men and women over four years at three different times.

In a “snapshot in time” at baseline, the researchers found that individuals consuming one or more soft drinks a day had a 48 percent increased prevalence of the metabolic syndrome compared to those consuming less than one soft drink daily.

In a longitudinal study of participants who were free of metabolic syndrome at baseline (6,039 person observations), consumption of one or more soft drinks a day was associated with a 44 percent higher risk of developing new-onset metabolic syndrome during a follow-up period of four years.

The researchers also observed that compared to participants who drank less than one soft drink daily, those who drank one or more soft drinks a day had a:

• 31 percent greater risk of developing new-onset obesity (defined as a body mass index [BMI] of 30 kilograms/meter2 or more);
• 30 percent increased risk of developing increased waist circumference;
• 25 percent increased risk of developing high blood triglycerides or high fasting blood glucose;
• 32 percent higher risk of having low HDL levels.
• A trend towards an increased risk of developing high blood pressure that was not statistically significant.

Researchers then analyzed a smaller sample of participants on whom data on regular and diet soft drink consumption was available from food frequency questionnaires. Participants who consumed one or more drinks of diet or regular soda per day had a 50 to 60 percent increased risk for developing new-onset metabolic syndrome, said Dhingra, who is also an attending physician at Alice Peck Day Memorial Hospital in New Hampshire. “It didn’t matter whether it was a diet or regular soft drink.”

“Results also don’t appear to be driven by the dietary pattern of soft drink users, i.e, by other food items that are typically consumed along with soft drinks,” Vasan said. “We adjusted in our analyses for saturated fat and trans fat intake, dietary fiber consumption, total caloric intake, smoking and physical activity, and still observed a significant association of soft drink consumption and risk of developing the metabolic syndrome and multiple metabolic risk factors.”

One explanation is that the fructose corn syrup in regular soft drinks causes weight gain, and can lead to insulin resistance and diabetes, Vasan said. “But then you would expect to see an association with regular soft drinks, but not diet soft drinks. Our findings suggest that this is not the case.”

Another possible explanation is that consuming more liquids is associated with a lesser degree of dietary compensation. Usually if you eat a large meal, then you’re inclined to eat a smaller amount at the next meal, Vasan said. But liquids don’t have the same degree of compensation as solids. If you drink a large amount of liquids at a meal, you are more likely to eat a larger amount at the next meal (compared to what you would eat had you consumed more solids at the prior meal).

Other theories are that the high sweetness of diet and regular soft drinks makes a person more prone to eat sweet items, or the caramel content in soft drinks may promote development of advanced glycation end products, complexes of sugars that can result in insulin resistance and can cause inflammation in experimental studies.

“These are all theories, and experts debate their importance,” Dhingra said. “Our study was observational, and so right now all we demonstrate is an association. We have not proven causality.”
Dhingra and Vasan called for further studies to replicate the results and to understand the mechanisms driving this association before recommendations can be made.

Other researchers included Thomas J. Wang, M.D.; Caroline S. Fox, M.D.; Lisa Sullivan, Ph.D.; Ralph B. D’Agostino, Ph.D.; James B. Meigs, M.D., M.P.H.; J. Michael Gaziano, M.D., M.P.H. and Paul F. Jacques, Ph.D.

Posted by dlifenews at 02:41 PM | Comments (1)

World-Renowned Photojournalist Rick Smolan Joins Novo Nordisk to Create

July 23, 2007 (PRNewswire) -- Rick Smolan, former Time, Life and National Geographic photographer and creator of the best-selling "Day in the Life" photo book series, will focus his lens next on the faces of people with type 2 diabetes -- a condition that is estimated to affect more than 18 million Americans(1) and is forecast to double by 2050(2). Type 2 diabetes accounts for about 90 percent to 95 percent of all diagnosed cases of diabetes(1), and rates have grown sharply in recent years as a result of the upsurge of obesity and physical inactivity in the United States(3).

The new project, called Meet the Face of Change(TM), will be a nationally touring photo exhibit that documents - and celebrates – the lives of a diverse group of people with type 2 diabetes who are making the changes they need to better manage their condition. To create the photo exhibit, Smolan is inviting people with type 2 diabetes to visit http://www.FaceOfChange-us.com to submit their photographs and share information about how they manage their diabetes. Smolan will work with a team of photo editors to review the submissions and to select the subjects who will be photographed and featured in the nationally touring exhibit. The Meet the Face of Change(TM) photo exhibit will feature the photographs, and accompanying personal stories, and will travel to major cities this year, culminating in New York. The deadline for submissions is August 30, 2007.

"Ultimately, it's our hope to create a rich photographic tableau of portraits that not only inspires others living with this condition but educates the public about the daily challenges and triumphs of people living with diabetes, especially as the disease continues to affect an ever- increasing number of Americans," said Smolan.

Many people with type 2 diabetes can control their blood glucose by following a healthy meal plan and exercise program, losing excess weight, and taking oral medications. However, others may need insulin as their diabetes progresses over time, and there are often fears about and barriers to insulin treatment(4). The exhibit seeks to showcase people who have overcome those barriers and manage their diabetes. The exhibit will be sponsored by Novo Nordisk, a world leader in diabetes.

"Changing Diabetes is our commitment as a company, and starts by recognizing that the status quo is not acceptable," said Martin Soeters, president of Novo Nordisk. "Meet the Face of Change(TM) is inspired by the millions of people with diabetes who are embracing change to get their diabetes in better control. Through this campaign, we hope to stimulate others to make changes that will improve their health, and to take action that will help reverse the negative trends we see with diabetes."

About Type 2 Diabetes

Diabetes is a serious chronic disease in which the body does not produce or properly use insulin, a hormone that is needed to convert sugar, starches, and other food into energy needed for daily life(5). People who have diabetes have high levels of glucose (sugar) in their blood(1).

Unlike type 1 diabetes, which occurs when the immune system destroys cells that secrete insulin(1) - no one knows why this occurs - in type 2 diabetes, family history often plays an important role, along with poor eating and exercise habits, and mainly affects people living a Western lifestyle(6). Type 2 diabetes is the most prevalent type of diabetes and results from insulin resistance (when the body makes too little insulin or cannot use insulin properly), usually combined with insulin deficiency(1).

The Centers for Disease Control estimate that more than 18 million of the nearly 21 million Americans with diabetes have type 2 diabetes, with an estimated 6 million or more unaware they have the disease(7). Rates of type 2 diabetes have grown exponentially in recent years - increasing by more than 50 percent in the last ten years alone(3). Type 2 diabetes is associated with traits such as older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and certain race/ethnic groups. African Americans, Hispanic/Latino Americans, American Indians, and some Asian Americans and Native Hawaiians or Other Pacific Islanders are at particularly high risk for type 2 diabetes(3). In addition, it is increasingly being diagnosed in children and adolescents(5).

About Rick Smolan

Rick Smolan has spent two decades finding ways to place himself and his projects directly in the path of the converging worlds of photography, design, publishing, and technology. Smolan created the best-selling "Day in the Life" photography series and is CEO of Against All Odds Productions, which specializes in the design and execution of large-scale global photographic projects that combine compelling story-telling with state-of-the-art technology.

Meet the Face of Change(TM) is sponsored by Novo Nordisk's portfolio of insulins.

Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 23,600 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.

References:
1. National Institute of Diabetes & Digestive & Kidney Diseases.
"National Diabetes Statistics,"
http://diabetes.niddk.nih.gov/dm/pubs/statistics/index.htm#7. Web site
accessed July 2007.
2. Centers for Disease Control. "CDC's Diabetes: Disabling Disease to
Double by 2050." http://www.cdc.gov/
nccdphp/publications/aag/pdf/diabetes.pdf. Web site accessed July 2007.
3. National Institute of Health. "Study Will Identify Best Treatment for
Type 2 Diabetes in Youth." http://www.nih.gov/news/pr/mar2004/niddk-
15.htm. Web accessed July 2007.
4. National Institute of Diabetes & Digestive & Kidney Diseases (NIH).
National Diabetes Clearinghouse (NDIC), "Treating Diabetes." Web site
accessed July 2007.
5. American Diabetes Association. "All About Diabetes: Overview,"
http://www.diabetes.org/about-diabetes.jsp, Web site accessed July 2007
6. American Diabetes Association. "The Genetics of Diabetes."
http://www.diabetes.org/genetics.jsp. Web site accessed July 2007.
7. Centers for Disease Control. "CDC's Diabetes Program: National
Diabetes Fact Sheet."
http://www.cdc.gov/diabetes/pubs/estimates05.htm#prev. Web site accessed
July 2007.

Posted by dlifenews at 09:25 AM | Comments (0)

New Role for Protein in Fat Cells May Improve Understanding of Obesity and Diabetes

July 20, 2007 (EurekAlert) -- Scientists have shown for the first time that a protein involved in the transfer of fat in the blood may also influence how fat cells store fat. Richard E. Morton and Lahoucine Izem, research scientists at the Cleveland Clinic Foundation, have shown that the protein, called cholesteryl ester transfer protein (CETP), is involved in the cellular storage and regulation of cholesterol and other fats and, as a result, probably has unexpected contributions to obesity and diabetes.

“CETP is known to shuttle different types of fat between lipoproteins – combinations of fat and protein that transport fats in the blood,” Morton says. “In this study, we show that CETP also shuttles fats inside fat cells between two separate areas and that fat cells with reduced levels of CETP are unable to process fats normally.”

The new study, to be published in the July 27 issue of the Journal of Biological Chemistry, was selected as a “Paper of the Week” by the journal’s editors, meaning that it belongs to the top one percent of papers reviewed in significance and overall importance.

Research performed during the past decade has shown that CETP affects how a type of fat called cholesteryl ester is moved from the blood plasma into cells. Since fat cells make abundant CETP, Morton and Izem decided to examine what CETP does inside a fat cell and what would happen to fat cells that are deficient in CETP.

The scientists noticed that fat cells lacking CETP could not make and store cholesterol, cholesteryl ester, and another fat called triglyceride like normal fat cells do. In CETP-deficient cells, cholesteryl ester and triglyceride accumulated in a cellular compartment called the endoplasmic reticulum (ER), while an abnormally low amount of these fats was seen in “lipid droplets” – local accumulations of fat in fat cells.

Morton and Izem suggest that, in normal cells, CETP transfers cholesteryl ester and triglyceride from the ER, where they are made, to the lipid droplets, where they are stored. In cells lacking CETP, only a fraction of both fats is carried from the ER to the lipid droplets. Also, since cholesterol is produced by breaking down cholesteryl ester in lipid droplets, lower levels of cholesteryl ester lead to smaller amounts of cholesterol in the droplets.

“CETP-deficient cells have unbalanced amounts of cholesterol and fats,” Morton says. “They have too much cholesteryl ester and triglycerides in the ER and not enough of them in the lipid droplets. Also, these cells sense that they have too much cholesterol, although they actually have low amounts of cholesterol. Overall, the cells don’t correctly control the amount of fats they make and store anymore.”

A consequence of the abnormal distribution of fats between cell compartments is that cholesteryl ester and triglycerides cannot be used easily. In normal cells, when these two fats accumulate in the droplets, they can be removed from the droplets and then used by the cell after the fats are broken down by enzymes called hydrolases. But since hydrolases are in the droplets and not in the ER, cells low in CETP cannot break down the fats they store as effectively, Morton and Izem say.

The scientists conclude that CETP is probably essential for lipid metabolism and storage in fat cells and that fat tissue is not only an energy storage tissue but also a major endocrine organ.

“CETP deficiency disrupts storage of important fats in fat cells, which can lead to insulin resistance – a major contributor to diabetes – and the abnormal release of cytokines, proteins that stimulate the immune system,” Morton says. “This unexpected contribution of CETP provides a new understanding of how our body stores and regulates fats and of conditions such as obesity and diabetes.”

Posted by dlifenews at 02:31 PM | Comments (0)

Rosiglitazone For Type 2 Diabetes -- Concern Over Side Effects

The latest findings from the Cochrane Library

July 19, 2007 (EurekAlert) - New studies are needed to assess the trade-offs between potential benefits and potential harms when rosiglitazone is used by people with type 2 diabetes.

This Cochrane Systematic Review analysed data from 18 trials that involved a total of 8432 people and found no evidence that rosiglitazone led to better patient outcomes when compared with other therapies. Diabetic control (as measured by levels of HbA1c) was no better in patients given rosiglitazone when compared to other antidiabetic drugs. Patient oriented outcomes such as mortality, diabetes related morbidity, or quality of life were not addressed in most studies.

In addition to confirming the known risk of edema (people taking the treatment are at twice the risk of developing this condition) and an increase in body weight up to 5.0 kg, the authors found evidence from one large study indicating increased cardiovascular risk and an enhanced risk in women of having broken bones.

In people with type 2 diabetes, their body has a reduced ability to cause cells to remove glucose from the blood. The resulting high levels of blood-glucose can cause considerable damage especially to the eyes, nerves and kidneys. Rosiglitazone is one of a range of drugs that increase cell’s sensitivity to insulin and therefore may restore some of the normal function.

“Unfortunately, the published studies where people have taken rosiglitazone for at least 24 weeks do not give relevant data about issues like mortality, morbidity, and changes in health-related quality of life,” says lead author Associate Professor Bernd Richter, who works at the Department of General Practice, in Duesseldorf.

“Studies on patient-oriented outcomes are urgently needed, although it is questionable whether new studies with rosiglitazone will be ethical given the fact that less dangerous therapeutic alternatives exist,” says Richter.

Posted by dlifenews at 04:48 PM | Comments (0)

Adult Type 2 Diabetes -- Poor Information on Diet, but Exercise Seems Good

July 18, 2007 (EurekAlert) - There are no high quality data to assess how well dietary treatments for type 2 diabetes work in people who have just been told they have the disease, but there is evidence that taking on exercise seems to be one way of improving blood sugar levels, according to the findings of a Cochrane Systematic Review.

Type 2 diabetes leaves a person at danger of having elevated levels of sugar (glucose) in their blood. This high sugar content then causes damage to blood vessels, which in turn harms many organs including the eyes, nerves, kidneys and heart.

When people are first diagnosed with this disease they are given dietary advice in the hope that this will enable them to take more control over the level of sugar in their blood. However, after searching published scientific literature, a team of Cochrane Researchers was unable to find high quality data that showed whether dietary advice did indeed alter the risk of developing long-term complications, affect overall quality of life or the likelihood of dying.

“We did find 36 published articles that reported work from 18 different trials which included a total of 1467 people with type 2 diabetes, but only a minority of these trials examined hard clinical endpoints such as death or vascular disease, and those that did offered no details; most talked about factors that are easier to measure such as weight or blood sugar control,” says lead researcher Nield, a researcher at the University of Teesside in Middlesbrough, UK.

The team did, however, find data suggesting that if people with type 2 diabetes increase the amount of exercise as an adjunct to dietary advice they do, then they can see an improvement in their blood sugar levels after six and twelve months.

“There is an urgent need for well-designed and well-reported studies which examine a range of interventions and see how they influence many of the features that are important in type 2 diabetes,” says Lucie Nield.

The researchers point out that there is some good news, in that one promising study is already underway.

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Rapid-Acting Insulin Analogues in Diabetes Mellitus Type 1 -- Superiority Not Proven

High-quality long-term studies are lacking -- Not all studies have been fully published

July 18, 2007 (EurekAlert) - There is currently no evidence available of a superiority of rapid-acting insulin analogues over human insulin in the treatment of adult patients with diabetes mellitus type 1. The evidential value and design of studies available so far are inadequate and do not allow conclusions regarding most patient-relevant therapy goals, such as the reduction in long-term complications or overall mortality. Due to the lack of data, the benefit of rapid-acting insulin analogues in children and adolescents is unclear. Although one of the manufacturers conducted long-term comparative studies in this group of patients, it is withholding some of the results. This is the result of the final report of the Institute for Quality and Efficiency in Health Care (IQWiG) which was published in June 2007 and for which an English-language summary is now available.

The German Federal Joint Committee commissioned IQWiG to compare the benefit of rapid-acting insulin analogues versus human insulin, as well as to compare the benefit of various rapid-acting insulin analogues with each other. IQWiG assessed all 3 rapid-acting insulin analogues approved in Germany: insulin aspart (tradename in Germany: Novorapid), insulin lispro (tradenames in Germany: Humalog, Liprolog), and insulin glulisine (tradename in Germany: Apidra).

Effects determinable after 6 months at the earliest
The literature search retrieved a total of 9 published comparative studies, in which patients were observed for at least 24 weeks. Only studies with this minimum duration were included, as they give patients sufficient time to adjust to the new medication, and to observe the treatment effects under stable application. Eight of these studies compared either insulin aspart or insulin lispro with human insulin; no such study was available for glulisine. The only study available that compared two analogues referred to glulisine and lispro.

No long-term studies on insulin pump therapy available
Regarding insulin pump therapy, no study lasting at least 24 weeks was available. Therefore, it remains unclear whether patients would benefit and which advantage patients would have by using this form of administration. The same applies to children and adolescents, as only fully published short-term studies are available in this population so far. The company Novo Nordisk sponsored 2 completed long-term studies in children and adolescents. However, to date, both studies have only been partially published. In contrast to the manufacturers Sanofi and Lilly, Novo Nordisk was not prepared to provide the information needed for the report.

Studies not blinded
The conclusions of the 9 studies included in the evaluation are only of limited robustness. None of the studies was blinded, i.e. both the patient and the physician knew which type of insulin was being injected. Without blinding, there is a danger that patients, knowing their type of insulin, behave differently, which would subsequently lead to a bias in the results of the study. Moreover, inconsistent statements on important issues, which could not be clarified, were often made in the study documents.

No conclusions on important therapy goals possible
Even though patients have been treated with insulin analogues for 10 years, it is still unclear as to how these types of insulin affect long-term complications of diabetes type 1, mortality, and the necessity of hospital admissions. Regarding the reduction in blood glucose levels (measured by means of HbA1c), patients treated with insulin aspart had, on average, lower levels. However, these statistical differences were so small that an effect on patients’ health is not to be expected. Insulin lispro may prevent nocturnal hypoglycaemia better than insulin glulisine. The only study that compared these insulin analogues provided first indications, but no reliable evidence.

Rules of a fair comparison violated
In some studies, patients treated with insulin analogues assessed their quality of life as higher and were more satisfied with treatment than patients who injected human insulin. IQWiG did not evaluate this finding as evidence of an additional benefit of insulin analogues, as it was not based on a fair comparison: In the human insulin group, patients were requested to adhere to a fixed injection-meal interval; this was not the case in the insulin analogue group. It is therefore unclear whether the larger treatment satisfaction was caused by the drug class itself, or by the different forms of application prescribed by physicians.

The role of rapid-acting insulin analogues in the treatment of diabetes type 2 was assessed in a separate commission; the relevant final report had already been published by IQWiG in December 2005. This report also came to the conclusion that evidence of an additional benefit of insulin analogues has yet to be provided.

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

Flavonoids in Orange Juice Make it a Healthy Drink, Despite the Sugar

July 18, 2007 (EurekAlert) -- Orange juice, despite its high caloric load of sugars, appears to be a healthy food for diabetics due to its mother lode of flavonoids, a study by endocrinologists at the University at Buffalo has shown. The study appeared in the June 2007 issue of Diabetes Care.

Flavonoids suppress destructive oxygen free radicals -- also known as reactive oxygen species, or ROS. An overabundance of free radicals can damage all components of the cell, including proteins, fats and DNA, contributing to the development of many chronic diseases, including heart disease and stroke as well as diabetes.

“Many major diseases are associated with oxidative stress and inflammation in the arterial wall, so the search for foods that are least likely to cause these conditions must be pursued,” said Paresh Dandona, M.D., Ph.D., head of the Diabetes-Endocrinology Center of Western New York and senior author on the study. “Our previous work has shown that 300 calories of glucose induces ROS and other proinflammatory responses,” said Dandona, who is Distinguished Professor of Medicine in the UB School of Medicine and Biomedical Sciences. “We hypothesized that 300 calories-worth of orange juice or of fructose would induce less oxidative stress and inflammation than caused by the same amount of calories from glucose.”

The resulting study involved 32 healthy participants between the ages of 20 and 40, who were of normal weight, with a body mass index of 20-25 kg/m2. Participants were assigned randomly and evenly into four groups, who would drink the equivalent of 300 calories-worth of glucose, fructose, orange juice or saccharin-sweetened water. Fasting blood samples were taken before the test and at 1, 2 and 3 hours after a 10-minute period to consume the drinks.

Results showed a significant increase in ROS within 2 hours in samples from the glucose group but not in those from the fructose, orange juice or water group. “We were intrigued by the fact that there was no increase in ROS or inflammation following orange juice consumption, even though its glucose concentration was the same as in participants in the glucose group,” said Dandona. “This raised the question of what in the juice was responsible for suppressing ROS generation: flavonoids and vitamin C or fructose"”

An additional round of test on the samples showed that neither fructose nor vitamin C suppressed the oxygen free radicals. However the two types of flavonoids in orange juice -- hesperetin and naringenin -- inhibited ROS generation by 52 percent and 77 percent, respectively.

“Our data are relevant to patients with diabetes,” said Dandona, “because stress from ROS and inflammation are increased significantly in this population and may contribute to development of atherosclerosis. Clearly the choice of foods that either don’t increase or actually decrease oxidative and inflammatory stress is important. “The search for safe non-inflammatory foods and diets must continue,” Dandona stressed, “especially since obesity, being overweight and type 2 diabetes are associated with oxidative stress and inflammation, and more than 60 percent of U.S. population is affected by these conditions.”

Posted by dlifenews at 04:51 PM | Comments (0)

Diabetics Experience More Complications Following Trauma

July 17, 2007 (EurekAlert) - Individuals with diabetes appear to spend more days in the intensive care unit, use more ventilator support and have more complications during hospitalization for trauma than non-diabetics, according to a report in the July issue of Archives of Surgery, one of the JAMA/Archives journals.

Approximately 17 million Americans have diabetes, with one-third remaining undiagnosed, according to background information in the article. These patients develop complications more frequently and do worse after an acute illness than individuals without diabetes. Studies show that diabetics do worse after being hospitalized for stroke, heart attack and heart surgery, but little is known about their outcomes after trauma.

Rehan Ahmad, D.O., and colleagues at the Penn State College of Medicine and Milton S. Hershey Medical Center, Hershey, Penn., used a statewide database to identify 12,489 patients with diabetes who were hospitalized at 27 trauma centers between 1984 and 2002. They then selected an additional 12,489 patients who were the same age and sex and had the same severity of injury but did not have diabetes for comparison.

There was no difference between the two groups in death rates or length of hospital stay. However, compared with patients who did not have diabetes, patients with diabetes:

• were more likely to experience any complication (23 percent vs. 14 percent)
• were more likely to require care in the intensive care unit (ICU) (38.4 percent vs. 35.9 percent)
• stayed in the ICU longer on average (7.6 days vs. 6.1 days)
• required longer duration of ventilator support (10.8 days vs. 8.4 days)
• developed more infections (11.3 percent vs. 6.3 percent)

“Patients with diabetes mellitus were less likely to be discharged to home and were more likely to require skilled nursing care after discharge compared with patients who did not have diabetes mellitus,” the authors write. “This may have accounted for the similarity in overall hospital length of stay between the diabetes mellitus and non–diabetes mellitus groups. In addition, improved diabetes mellitus treatment modalities and advances in critical care and trauma resuscitation likely contributed to comparable mortality rates between the two groups, despite the greater morbidity associated with having diabetes mellitus.”

Previous studies have demonstrated that diabetes reduces the effectiveness of some components of the immune system, the authors continue. “Results from this study confirm that patients with diabetes mellitus are at higher risk for developing an infectious complication, despite matching for sex, age and the severity of injury,” they conclude. “They also require a higher level of care, which adds to the cost of hospitalization. Future studies are needed to evaluate the effect of improved glycemic control on hospitalized patients with diabetes mellitus involved in trauma.”

Posted by dlifenews at 10:02 AM | Comments (0)

Gene Discovered for Type 1 Diabetes in Children

July 16, 2007 (Newswise) — Pediatrics researchers at The Children’s Hospital of Philadelphia and McGill University in Montreal have identified a gene variant that raises a child’s risk for type 1 diabetes, formerly called juvenile diabetes. As investigators continue to pinpoint genes contributing to diabetes, they have their eyes on providing a scientific basis for designing better treatments and preventive measures for the disease.

The research adds a new gene and new knowledge to the four genes previously discovered for type 1 diabetes, in which the immune system destroys insulin-producing beta cells in the pancreas and makes patients dependent on frequent insulin injections to keep the body’s blood sugar under control. As the project continues, the study team expects to identify additional genes (perhaps as many as 15 or 20) thought to interact with each other in the disease.

The study appeared July 15 in an advance online letter in the journal Nature.

“The genotyping technology we now have available has revolutionized the way we can ask and answer research questions,” said the study’s lead author, Hakon Hakonarson, M.D., Ph.D., the director of the Center for Applied Genomics at The Children’s Hospital of Philadelphia. “Unlike the previous technology, which was quite limited and dealt largely with relatively rare gene variants, we can now detect common genetic variants that are important in large numbers of individuals, and begin to understand how multiple genes interact in complex diseases such as diabetes.”

In the discovery phase of the study, the investigators examined the genomes of 1,046 children with type 1 diabetes. These DNA samples came from patients and families followed in pediatric diabetes clinics in Philadelphia and four Canadian cities. Specifically, the researchers compared the genomes of 563 patients with type 1 diabetes with those of 1,146 matched control subjects. Those results were combined with those obtained from an independent analysis of 483 family trios, in which the genomes of a child with the disease and both parents were examined.

The researchers confirmed the four previously identified locations for genes contributing to type 1 diabetes, but also uncovered a new type 1 diabetes locus on chromosome 16, occupied by a gene called KIAA0350. The team then replicated this discovery in yet another independent cohort of 1,333 children with the disease from the Type 1 Diabetes Genetics Consortium, which includes children of European descent in Europe, North America and Australia, as well as in 390 additional type 1 diabetes family trios from Canada.

Constantin Polychronakos, M.D., director of Pediatric Endocrinology at McGill University and senior author of the study, said that better knowledge of genes that predispose to type 1 diabetes may later enable physicians to screen newborns to predict those at high risk for the disease.

The gene implicated in the current research, KIAA0350, is known to be active almost exclusively in immune cells. Although scientists do not currently know the exact function of the protein the gene encodes, other research has predicted that it produces a protein called C-type lectin that is located on the surface of immune cells and binds to groups of sugars in the body.

“The role of KIAA0350 needs to be investigated,” said Hakonarson. “However, a special cell type called a natural killer (NK) cell expresses this gene abundantly, although at different levels based on these gene variants. Our hypothesis is that a special mutation in KIAA0350 may influence the sugar binding of the protein, and trigger an autoimmune response that activates these NK cells in such a way that they attack and destroy the islet cells in the pancreas, resulting in type 1 diabetes. A particular version of the gene protects against this inappropriate autoimmune response, while a different version of the gene makes it more likely to happen. ”

Although much research remains to be done, better understanding of the disease process may guide doctors to new and improved therapies. “If we know the gene pathways that give rise to type 1 diabetes, we hope to intervene early in life with targeted drugs or cell therapies to prevent the disease from developing,” said Polychronakos.

The current research used a technique called genome-wide association, in which highly automated analytic equipment rapidly scans each patient’s DNA for more than half a million genetic markers. It was performed at the Center for Applied Genomics at Children’s Hospital. The Center’s tools spell out a patient’s genotype—the specific pattern of variations among an individual’s 30,000 genes. Established in the summer of 2006, the center is taking on one of the largest genotyping projects in the world, and is the largest one dedicated to genetic analysis of childhood diseases.

“This study is the first one that our center has published on a gene associated with a complex childhood disease, but we have many projects under way and several other papers in press,” said Hakonarson. “Our goal at the Center is to discover the major disease-causing variants and genes that influence complex pediatric diseases, thus providing a scientific foundation that is based in biology for translating those discoveries into successful treatments.”

Among its current projects, the Center’s investigators are focused on identifying genes involved in pediatric asthma, allergy, obesity, attention-deficit hyperactivity disorder, autism, inflammatory bowel disease, hypertension, juvenile rheumatoid arthritis and the pediatric cancer neuroblastoma. The Center recently contributed 4,000 DNA samples to an industry-hosted database that serves as a free repository of control samples for researchers seeking gene variations in diseases.

Financial support for the study came from Genome Canada through the Ontario Genomics Institute, the Juvenile Diabetes Research Foundation and The Children’s Hospital of Philadelphia. Hakonarson’s and Polychronakos’ co-authors were affiliated with the University of Pennsylvania School of Medicine, the University of Manitoba, the Children’s Hospital of Eastern Ontario, the University of Ottawa, and Markham-Stoufville Hospital of Markham, Ontario.

About The Children's Hospital of Philadelphia: The Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking third in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 430-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit http://www.chop.edu.

Posted by dlifenews at 04:32 PM | Comments (0)

While Most Diabetes Drugs Provide Similar Glucose Control, Some Offer Important Advantages, New Review Shows

July 16, 2007 (AHRQ) - Most oral medications prescribed for type 2 diabetes are similarly effective for reducing blood glucose, but the drug metformin is less likely to cause weight gain and may be more likely than other treatments to decrease so-called bad cholesterol, according to a report funded by the Department of Health & Human Services's (HHS) Agency for Healthcare Research and Quality (AHRQ). A version of the analysis was posted today in the online version of Annals of Internal Medicine.

The federally funded analysis is based on scientific evidence found in 216 published studies. The report summarizes the effectiveness, risks, and estimated costs for 10 drugs: acarbose (sold as Precose), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Micronase, DiaBeta, Glynase PresTab), metformin (Glucophage, Riomet, Fortamet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia).

Type 2 diabetes is an increasingly common chronic disease that occurs in people who have difficulty converting glucose (a sugar) into energy. Blood glucose levels are high either because their cells are resistant to insulin (a hormone that helps convert glucose into energy) or because their pancreas does not produce enough insulin. Diabetes can cause severe problems with the heart, eyes, kidneys, and nerves. Obesity increases the risks of developing type 2 diabetes. From 1980 through 2005, the number of Americans diagnosed with diabetes soared from 5.6 million to 15.8 million.

"As more people are diagnosed with type 2 diabetes and with the growing array of treatment choices, this is a landmark review," said AHRQ Director Carolyn M. Clancy, M.D. "This summary of scientific evidence is not only an important tool for clinicians and patients seeking the most appropriate therapy, but it also points out in what areas we need more research to confront this disease."

As new classes of oral diabetes medications have become available, patients and clinicians have faced a growing list of treatment options. Earlier scientific reviews have highlighted some differences between medications, but AHRQ's new analysis is the first to summarize evidence on the effectiveness and adverse events for all approved oral medications commonly used in the United States for type 2 diabetes.

Diabetes patients typically are monitored with tests that check the percentage of hemoglobin A1c (HbA1c) in their blood. Checking for HbA1c is a more reliable indicator of chronic high blood sugar than checking blood glucose itself. According to the AHRQ review, most diabetes drugs offer about a one point absolute reduction in HbA1c. In those cases, for example, a diabetes patient's HbA1c might drop from 8 to 7 (with 5 being normal in patients who don't have diabetes). Nateglinide, acarbose, and miglitol lower HbA1c by about half that much. Combining diabetes medications, evidence shows, often works better at reducing HbA1c.

AHRQ's analysis of published studies, completed by the Agency's Johns Hopkins University Evidence-based Practice Center in Baltimore, also concluded:

Metformin and acarbose do not increase weight among diabetes patients. Other diabetes drugs (glimepiride, glipizide, glyburide, pioglitazone, repaglinide, and rosiglitazone) have been shown to increase weight by an average of 2 pounds to 11 pounds.

Blood levels of low-density lipoprotein, which is known as "bad cholesterol" because it may amplify risks of heart attack and stroke, consistently decrease (by about 10 milligrams per deciliter) in patients taking metformin and increase (by similar amounts) in patients taking rosiglitazone and pioglitazone.

Pioglitazone and rosiglitazone cause a small but significant increase in high-density lipoprotein, often called "good cholesterol" because it promotes the breakdown and removal of cholesterol from the body.

Glimepiride, glipizide, glyburide, and repaglinide are associated with hypoglycemia (when blood glucose levels go too low) more than other diabetes drugs.

Metformin and acarbose are generally more likely than other diabetes medications to cause gastrointestinal problems such as diarrhea. Patients who used metformin alone were more likely to experience problems than those using the drug at a lower dose in combination with glimepiride, glipizide, glyburide, pioglitazone, or rosiglitazone.

Patients who take pioglitazone and rosiglitazone have a greater risk of congestive heart failure compared with those who take metformin, glimepiride, glipizide, or glyburide. While one recent analysis raised the possibility that rosiglitazone may also increase heart attack risks, authors of the AHRQ analysis concluded that current evidence is not sufficient to make a meaningful assessment.

More, longer studies are needed to understand the impact of oral diabetes drugs on patients' quality of life and whether long-term use causes adverse side effects or reduces important complications of diabetes such as heart disease and kidney disease. Additional research is needed to study interactions between the drugs and to compare therapeutic combinations of the drugs, according to the report.

The report released today, Comparative Effectiveness and Safety of Oral Diabetes Medications for Adults with Type 2 Diabetes, is the newest analysis from AHRQ's Effective Health Care program, authorized by the Medicare Prescription Drug, Improvement and Modernization Act. That program represents an important federal effort to compare alternative treatments for health conditions and make the findings public. The program is intended to help patients, doctors, nurses, and others choose the most effective treatments. Information can be found at http://www.effectivehealthcare.ahrq.gov.

For more information, please contact AHRQ Public Affairs: (301) 427-1855 or (301) 427-1998.

Posted by dlifenews at 10:07 AM | Comments (1)

Common Rheumatoid Arthritis Treatment Shows Potential For Diabetes Prevention

July 12, 2007 (Science Daily) — Far fewer rheumatoid arthritis patients treated with the drug hydroxychloroquine (HCQ) went on to develop diabetes compared to those who never took the drug, according to a 20-plus-year University of Pittsburgh School of Medicine-led study reported today in the Journal of the American Medical Association. In addition, those using HCQ who did develop diabetes were less likely to take medications to manage their disease after diagnosis.

The multi-center observational study of 4,905 adults with rheumatoid arthritis (RA) found that relative risk progressively declined by as much as 77 percent after four years of treatment with HCQ, a common antimalarial medication that also is used for rheumatoid arthritis and other autoimmune disorders.

Additional participating centers in the study are Stanford University, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), one of the National Institutes of Health (NIH) and the University of Cincinnati. Co-investigators at Stanford have directed the project database since its inception with support from the NIH.

"This reduction in risk persisted even after adjusting for other diabetes risk factors among these patients, such as body-mass index, degree of disability and use of corticosteroids," said rheumatologist Mary Chester M. Wasko, M.D., M.Sc., associate professor of medicine, University of Pittsburgh School of Medicine. Because people with RA tend to be less active and take corticosteroids that can cause weight gain, they are often considered to be at higher risk for developing diabetes, a disease in which blood sugar levels become abnormally high because of the body's inability to use or produce the hormone insulin.

"Another interesting finding was that the rheumatoid arthritis patients who developed diabetes were less likely to need blood sugar-lowering medication to manage their disease," said Dr. Wasko, whose clinical research has focused on long-term health improvement in patients with RA. "However, it is most exciting to consider that this drug might be appropriate for people with pre-diabetes as a preventive therapy -- much in the same way as a daily baby aspirin is suggested for people at high risk for heart disease."
Nationally, diabetes is the fifth leading cause of death, according to the American Diabetes Association. Many people first become aware of the disease when confronted with one of its life-threatening complications such as heart disease, blindness, high blood pressure, stroke, kidney disease or circulatory problems that can lead to amputation.

Results show that HCQ's association with reduction in diabetes risk is comparable or superior to that of a number of other drugs studied in clinical trials for diabetes prevention and treatment, including rosiglitazone, hormones, metformin, acarbose and ramipril. And recent questions have arisen concerning rosiglitazone, marketed as Avandia, and a reported increased risk of heart attack.

Although HCQ is not without side effects -- nausea, headache and dizziness, for example -- the drug has a long history of being generally safe and well-tolerated. In addition, Dr. Wasko and her colleagues observed no apparent negative interactions between HCQ and other drugs commonly used by RA patients, such as methotrexate and prednisone. An important limitation of the study, however, is that investigators used self-report information from patients collected in follow-up twice yearly that did not include confirmation by laboratory tests.

Other studies of the blood sugar-lowering effects of HCQ have shown minimal use for the drug as a treatment for people with established diabetes, Dr. Wasko continued, stressing the treatment's real promise may be prevention.

"HCQ already has a role in long-term treatment for RA, potentially moderating lipids and having a weak anti-clotting effect. But, optimistically speaking, endocrinologists can identify people who are at high risk for diabetes, due to obesity, family history, lipid profile or other characteristics. HCQ may also have a role in delaying onset of diabetes," Dr. Wasko said. "More research is needed to verify our findings in people with RA, and also to determine how this medicine works. But my ultimate hope is that this relatively inexpensive, safe drug will be studied as a way to reduce diabetes risk for people who do not have RA."

In addition to Dr. Wasko, study authors are Helen B. Hubert, M.P.H., Ph.D., James F. Fries, M.D., and Vijaya Bharathi Lingala, Ph.D., all of Stanford University Medical Center; Jennifer R. Elliott, M.D., University of Pittsburgh School of Medicine; Michael E. Luggen, M.D., University of Cincinnati; and Michael M. Ward, M.D., M.P.H., Intramural Research Program, NIAMS. The study was conducted with support from the Arthritis Foundation of Western Pennsylvania, NIAMS and the Intramural Research Program, NIAMS.

Financial disclosure: Dr. Wasko is a consultant to Centocor in cardiovascular outcomes in ongoing rheumatoid arthritis clinical trials and has been a co-investigator in a Merck-sponsored study of blood clot markers in rheumatoid arthritis and osteoarthritis. She also has received payment as site principal investigator for clinical trials for rheumatoid arthritis drugs sponsored by Sanofi-Aventis (ending in 2002), Centocor, Roche, Novartis and Human Genome Sciences. Hydroxychloroquine, marketed as Plaquenil ® is manufactured by Sanofi-Aventis. In its generic form, the drug has multiple manufacturers.

Note: This story has been adapted from a news release issued by University of Pittsburgh Schools of the Health Sciences.

Posted by dlifenews at 10:46 AM | Comments (0)

Class of Medications May Offer Alternative Option for Treating Type 2 Diabetes

July 11, 2007 (EurekAlert) - A review of previous studies indicates that use of a class of medications known as “incretin-based therapy”, which act via certain pathways that affect glucose metabolism may provide modest effectiveness and favorable weight change outcomes for the treatment of type 2 diabetes and may represent an alternative to other hypoglycemic therapies, according to an article in the July 11 issue of JAMA.

Current therapies for type 2 diabetes are often limited by adverse effects such as weight gain or hypoglycemia (low blood sugar). A more recent class of treatment to address these issues is incretin therapy, which involves glucose-stimulated insulin secretion by intestinally derived peptides, which are released in the presence of glucose or nutrients in the gut, according to background information in the article. In October 2006 the Food and Drug Administration approved the first oral incretin enhancer, sitagliptin, a selective DPP4 inhibitor (a class of oral hypoglycemics), for use as monotherapy or in combination with other medications. The effectiveness of this class of medications in managing type 2 diabetes is not well understood.

Renee E. Amori, M.D., of Tufts-New England Medical Center, Boston, and colleagues conducted a meta-analysis of 29 studies to assess the effectiveness and safety of incretin-based therapy (GLP-1 analogues and DPP4 inhibitors) in nonpregnant adults with type 2 diabetes.

“Our analysis of randomized controlled trials showed that incretin-based therapy with GLP-1 analogues or DPP4 inhibitors in adults with type 2 diabetes is moderately effective in improving glycemia, with greater reductions in postprandial [after a meal] glycemia and favorable (GLP-1 analogues) or neutral (DPP4 inhibitors) effects on weight. Glucagon [a hormone secreted by the pancreas]-like peptide 1 analogues were associated with gastrointestinal adverse effects, while DPP4 inhibitors had a slightly increased risk of infection (nasopharyngitis [inflammation of the nasal passages] and urinary tract infection) and headache,” the authors write.

“Incretin therapy offers an alternative option to currently available hypoglycemic agents for nonpregnant adults with type 2 diabetes with modest efficacy and a favorable weight change profile,” they write. “Individuals with mild diabetes, suggesting an adequate pancreatic beta cell reserve, who are at risk of hypoglycemic sequelae and in need of weight loss may benefit from this new class. However, these new classes of hypoglycemic agents will need continued evaluation both in long-term efficacy and safety controlled trials and in clinical practice to assess their effectiveness and safety profile to determine their role among the many available and well-established therapies for type 2 diabetes.”

Posted by dlifenews at 10:57 AM | Comments (0)

Selenium Supplements Linked with Increased Risk for Diabetes in 8-Year Study

July 10, 2007 (Eurekalert )-- A new analysis of data from a large national study found that people who took a 200 microgram selenium supplement each day for almost eight years had an increased risk of developing type 2 diabetes than those who took a placebo or dummy pill.

The data came from the Nutritional Prevention of Cancer Trial (NPC), a large randomized, multi-center, clinical trial from the eastern United States, designed to evaluate whether selenium supplements prevent skin cancer. In the study being published, researchers selected 1,202 participants who did not have diabetes when they were enrolled in the NPC Trial. Half received a 200 microgram selenium supplement and half received a placebo pill for an average of 7.7 years.

Saverio Stranges, MD, PhD, lead author of the study, says that the findings from this study suggest that selenium supplements do not prevent diabetes and that they might be harmful. “At this time, the evidence that people should take selenium supplements is extremely limited. We have observed an increased risk for diabetes over the long term in the group of participants who took selenium supplements.”

Dr. Stranges is currently working at Warwick Medical School, UK, but previously worked at the State University of New York at Buffalo. Other authors of the article include Mary E. Reid, PhD, and James R. Marshall, PhD, researchers at the Roswell Park Cancer Institute in Buffalo.

Selenium is a naturally occurring trace mineral present in soil and foods. The body need selenium in minute amounts to aid in metabolism. Selenium supplements are widely promoted on the Internet for conditions ranging from cold sores and shingles to arthritis and multiple sclerosis. They are sold to prevent aging, enhance fertility, prevent cancer and get rid of toxic minerals such as mercury, lead and cadmium.

Selenium supplements have shown some promise in preventing prostate cancer. Because of selenium’s antioxidant activities, some scientists feel it might be effective against diabetes.

In the current study, 58 out of 600 participants in the selenium group and 39 out of 602 participants in the placebo group developed type 2 diabetes. After 7.7 years of follow-up, the relative risk rate was approximately 50 percent higher among those randomly selected for the selenium group than among those randomly placed in the placebo group.

The results consistently showed higher risks of disease among participants receiving selenium across subgroups of baseline age, gender, and smoking status. However, the selenium supplements had no impact on the most overweight participants. The risk of developing diabetes tended to be higher in people who had higher blood selenium levels at the start of the study.

Dr. Stranges said, “No single study can provide the answer to a scientific question, but at this time, selenium supplementation does not appear to prevent type 2 diabetes, and it may increase risk of the disease. However, our understanding of the mechanisms whereby selenium would increase risk of diabetes is very limited at this time and this issue needs to be further explored. Nevertheless, I would not advise patients to take selenium supplements greater than those in multiple vitamins.”

About 60 percent of Americans take multivitamin pills, many of which contain between 33 and 200 micrograms of selenium, in addition to the selenium taken in from food and the air. The RDA (recommended dietary allowance) for selenium varies by age. For people aged 14 and over, 55 micrograms per day is recommended for the body to function normally.

Dr. Stranges said that selenium levels in soil in United States are higher than the minimum needed to optimize metabolism, so people in the United States should not need to take selenium supplements greater than those in multivitamin supplements.

In an accompanying editorial, Eliseo Guallar, MD, DrPH, from Johns Hopkins University Bloomberg School of Public Health, says the article is “more bad news for supplements.” He says that the NPC trial is the largest and longest experimental study available comparing selenium supplements to placebo, that selenium has a narrow therapeutic range and that at high levels, it can be toxic.

“What the U.S. public needs to know,” Dr. Guallar says, “is that most people in the United States have adequate selenium in their diet. Moreover, taking selenium supplements on top of an adequate dietary intake may cause diabetes.”

Posted by dlifenews at 02:59 PM | Comments (0)

Boosting Key Milk Nutrients May Help Lower Type 2 Diabetes Risk

New research finds combination of calcium and vitamin D may offer protection against type 2 diabetes

July 10, 2007 (EurekAlert) – Most Americans fail to get the calcium and vitamin D they need, but this shortfall could be affecting more than their bones. It may, at least in part, be one reason behind the epidemic of type 2 diabetes, suggests new research conducted at Tufts University. Drinking more milk – a leading source of calcium and vitamin D in the American diet – could help decrease the risk of type 2 diabetes by nearly 15 percent, according to the new meta-analysis and review published in the Journal of Clinical Endocrinology & Metabolism (1).

In the thorough analysis of previously published studies, the researchers found chronically low levels of vitamin D were linked to as high as 46 percent greater risk of type 2 diabetes. Yet boosting vitamin D alone would likely have little effect in healthy adults. Instead, the researchers suggested that a combination of vitamin D and calcium, like that found in milk, would have the greatest potential to help prevent diabetes, especially among those at highest risk for the disease.

Examining the intake of milk and milk products specifically, the researchers found there was nearly a 15 percent lower risk for type 2 diabetes among individuals with the highest dairy intake (3-5 servings per day) compared to those getting less than 1 ½ servings each day.

Most of the studies assessed were observational and the limited number of intervention trials makes definitive conclusions difficult, yet the Tufts researchers suggest calcium and vitamin D may affect the body’s ability to produce or utilize insulin, the hormone the body makes to process sugar that is impaired in those with diabetes and pre-diabetes.

Beside calcium and vitamin D, milk is the primary beverage source of magnesium, which a second meta-analysis found may also reduce the risk of type 2 diabetes (2). The analysis concludes that for every 100 milligram increase in magnesium up to the recommended dietary intake, the risk of developing type 2 diabetes decreased by 15 percent.

Type 2 diabetes and insulin resistance syndrome (or pre-diabetes) affect a staggering 75 million Americans and death rates from diabetes have increased nearly 45 percent over the past 20 years, elevating the importance of finding new ways to treat and prevent this deadly disease.

Milk is a primary source of calcium and vitamin D in the American diet. In fact, government reports indicate that more than 70 percent of the calcium in our nation’s food supply comes from milk and milk products. Additionally, milk is one of the few food sources of vitamin D, which is fast emerging as a “super nutrient.”

The recommended three servings of lowfat or fat-free milk provides 900 mg of calcium, 300 IU of vitamin D and 80 mg of magnesium daily.

Posted by dlifenews at 10:53 AM | Comments (0)

Common Rheumatoid Arthritis Treatment Shows Potential for Diabetes Prevention

July 10, 2007 (EurekAlert) – Far fewer rheumatoid arthritis patients treated with the drug hydroxychloroquine (HCQ) went on to develop diabetes compared to those who never took the drug, according to a 20-plus-year University of Pittsburgh School of Medicine-led study reported today in the Journal of the American Medical Association. In addition, those using HCQ who did develop diabetes were less likely to take medications to manage their disease after diagnosis.

The multi-center observational study of 4,905 adults with rheumatoid arthritis (RA) found that relative risk progressively declined by as much as 77 percent after four years of treatment with HCQ, a common antimalarial medication that also is used for rheumatoid arthritis and other autoimmune disorders.

Additional participating centers in the study are Stanford University, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), one of the National Institutes of Health (NIH) and the University of Cincinnati. Co-investigators at Stanford have directed the project database since its inception with support from the NIH.

“This reduction in risk persisted even after adjusting for other diabetes risk factors among these patients, such as body-mass index, degree of disability and use of corticosteroids,” said rheumatologist Mary Chester M. Wasko, M.D., M.Sc., associate professor of medicine, University of Pittsburgh School of Medicine. Because people with RA tend to be less active and take corticosteroids that can cause weight gain, they are often considered to be at higher risk for developing diabetes, a disease in which blood sugar levels become abnormally high because of the body’s inability to use or produce the hormone insulin.

“Another interesting finding was that the rheumatoid arthritis patients who developed diabetes were less likely to need blood sugar-lowering medication to manage their disease,” said Dr. Wasko, whose clinical research has focused on long-term health improvement in patients with RA. “However, it is most exciting to consider that this drug might be appropriate for people with pre-diabetes as a preventive therapy – much in the same way as a daily baby aspirin is suggested for people at high risk for heart disease.”

Nationally, diabetes is the fifth leading cause of death, according to the American Diabetes Association. Many people first become aware of the disease when confronted with one of its life-threatening complications such as heart disease, blindness, high blood pressure, stroke, kidney disease or circulatory problems that can lead to amputation.

Results show that HCQ’s association with reduction in diabetes risk is comparable or superior to that of a number of other drugs studied in clinical trials for diabetes prevention and treatment, including rosiglitazone, hormones, metformin, acarbose and ramipril. And recent questions have arisen concerning rosiglitazone, marketed as Avandia, and a reported increased risk of heart attack.

Although HCQ is not without side effects – nausea, headache and dizziness, for example – the drug has a long history of being generally safe and well-tolerated. In addition, Dr. Wasko and her colleagues observed no apparent negative interactions between HCQ and other drugs commonly used by RA patients, such as methotrexate and prednisone. An important limitation of the study, however, is that investigators used self-report information from patients collected in follow-up twice yearly that did not include confirmation by laboratory tests.

Other studies of the blood sugar-lowering effects of HCQ have shown minimal use for the drug as a treatment for people with established diabetes, Dr. Wasko continued, stressing the treatment’s real promise may be prevention.

“HCQ already has a role in long-term treatment for RA, potentially moderating lipids and having a weak anti-clotting effect. But, optimistically speaking, endocrinologists can identify people who are at high risk for diabetes, due to obesity, family history, lipid profile or other characteristics. HCQ may also have a role in delaying onset of diabetes,” Dr. Wasko said. “More research is needed to verify our findings in people with RA, and also to determine how this medicine works. But my ultimate hope is that this relatively inexpensive, safe drug will be studied as a way to reduce diabetes risk for people who do not have RA.”

Posted by dlifenews at 10:50 AM | Comments (0)

Pumpkin: A Fairytale End to Insulin Injections?

July 8, 2007 (EurekAlert) - Compounds found in pumpkin could potentially replace or at least drastically reduce the daily insulin injections that so many diabetics currently have to endure. Recent research reveals that pumpkin extract promotes regeneration of damaged pancreatic cells in diabetic rats, boosting levels of insulin-producing beta cells and insulin in the blood, reports Lisa Richards in Chemistry & Industry, the magazine of the SCI.

A group, led by Tao Xia of the East China Normal University, found that diabetic rats fed the extract had only 5% less plasma insulin and 8% fewer insulin-positive (beta) cells compared to normal healthy rats (Journal of the Science of Food and Agriculture, 87(9) 1753-7 2007).

Xia says: ‘pumpkin extract is potentially a very good product for pre-diabetic persons, as well as those who have already developed diabetes.’ He adds that although insulin injections will probably always be necessary for these patients, pumpkin extract could drastically reduce the amount of insulin they need to take.

David Bender, sub-dean at the Royal Free and University College Medical School, London, says: ‘this research is very exciting… the main finding is that feeding pumpkin extract prevents the progressive destruction of pancreatic beta-cells… but it is impossible to say whether pumpkin extract would promote regeneration in humans.’ He added: ‘I think the exciting thing is that this may be a source of a medication that could be taken by mouth.’

The protective effect of pumpkin is thought to be due to both antioxidants and D-chiro-inositol, a molecule that mediates insulin activity. Boosting insulin levels has the effect of lowering blood sugar levels, which reduces levels of oxidative oxygen species that damage beta-cell membranes, preventing further damage and allowing for some regeneration. Beta cells levels in the diabetic rats are, however, unlikely ever to reach that of controls, because some of the cells will have been damaged beyond repair.

Diabetes affects more than 230m people, almost 6% of the world's adult population, according to the World Diabetes Foundation. The rats used in this study represent type I diabetes, but the researchers believe the pumpkin extract may also play a role in type II diabetes.

Posted by dlifenews at 12:08 PM | Comments (1)

Cholesterol Drug Hits Diabetes with One-Two Punch, Tulane Study Says

July 6, 2007 (EurekAlert) – Patients with type 2 diabetes may soon be able to control their glucose and their cholesterol levels with a single drug, according to a study led by Vivian A. Fonseca, professor of medicine and pharmacology at Tulane University School of Medicine and chief of the Tulane University Health Sciences Center Diabetes Program.

Results from the clinical trial demonstrated that the compound colesevelam HCl, in combination with Sulfonylurea-based therapy in patients with inadequately controlled type 2 diabetes, achieved significantly reduced glucose levels versus those in the study taking a placebo. The study was recently presented at the American Association of Clinical Endocrinologists’ 16th Annual Meeting and Clinical Congress.

“People with uncontrolled type 2 diabetes and high cholesterol face a number of challenges in keeping their glucose levels and cholesterol in check. This study demonstrated the potential to improve two important metabolic parameters with one drug,” says Fonseca.

Patients who received colesevelam HCl were shown in the study to have significant reductions in blood sugar levels, and participants’ lipid profiles in the colesevelam HCl group also showed substantial improvement over placebo. An application for the commercial production and sale of the drug is currently being assessed by the U. S. Food and Drug Administration.

The American Diabetes Association estimates that 20.8 million people in the United States have diabetes and over 90 percent of these have type 2 diabetes. The Association recommends that these patients control their glucose levels, keeping their blood sugar level at less than 7 percent. The National Cholesterol Education Program recommends that patients with type 2 diabetes keep their cholesterol levels in check and target a goal of less than 100 mg/dL for “bad cholesterol” levels in the blood.

Posted by dlifenews at 12:12 PM | Comments (0)

Alternative Medicines Need to be Considered in Diabetes Management

July 5, 2007 (EurekAlert) - People with diabetes are risking their health by not discussing their use of complementary and alternative therapies with the health professionals managing their conventional treatment.

A review of the international health literature has shown nutritional supplements and herbal medicines are the most commonly used complementary and alternative therapies in diabetes.

Annie Chang, a PhD candidate in Griffith’s School of Nursing, said while some products may have benefits for patients, they can also have side effects in their own right or interact with conventional medications.

“Fenugreek for example, used as a supplement, may affect blood sugar levels but patients are already on other blood sugar lowering medications as well.”

While the prevalence of use varies widely between different countries (17-72%), her review suggests nearly half of people living with diabetes supplement their conventional medicines with some form of alternative therapy.

Women, over 65-year-olds, those who had been living with diabetes for longer, and people interested in self management of their condition were the most likely to use alternative therapies.

“People will tell their alternative practitioners that they are using Western medicines but the vast majority will not discuss their alternative therapies with a doctor or other healthcare professional,” she said.

Ms Chang, who has also surveyed more than 300 diabetics in Taiwan, said people feared their doctor would not be interested in discussing alternative medicines or that they might ‘get into trouble’ for taking them.

“The evidence is that patients are using these products and may even reduce their conventional medicine doses and modify the timing of doses so they aren’t taking both together.”

“While it might be impossible for Western medicine to learn all about complementary and alternative therapies, healthcare professionals do need to be included in discussions about them so we can document their use and be aware of any potential problems for our patients.”

Posted by dlifenews at 11:34 AM | Comments (0)

Early Indicator of Kidney Disease May Also Predict Risk of Pre-Diabetes

July 3, 2007 (EurekAlert) -- A blood component called cystatin C, used to test for early-stage kidney impairment, also may be a very early marker for those at risk of developing a condition known as pre-diabetes, a study conducted by researchers at the University at Buffalo has shown. Pre-diabetes is diagnosed when the amount of glucose in the bloodstream begins to rise and remain above normal, an indication that glucose is not being absorbed properly by cells.

An estimated 54 million people Americans have been diagnosed with pre-diabetes, which, if not arrested, often develops into full-blown Type 2 diabetes, a serious chronic disease linked to heart disease, stroke, kidney failure, blindness and nerve damage.

UB researchers report in the July 2007 issue of Diabetes Care that high levels of cystatin C were associated with a three-fold risk of progression to pre-diabetes in their study population.

“It’s important to identify people at risk of pre-diabetes very early, because you can prevent this condition from developing by making changes in diet and lifestyle,” said Richard P. Donahue, Ph.D., first author on the study.

“If further studies support our finding, testing for cystatin C could become an important part of a standard physical examination. Preventive measures could be in place before glucose intolerance has a chance to develop and take its toll.”

Donahue is an associate professor of social and preventive medicine in the UB School of Public Health and Health Professions.

The cystatin C investigation is based on the Western New York Health Study, conducted between 1996 and 2001, in which researchers collected baseline information on a number of health indicators, including fasting glucose, in a randomly selected cohort of healthy Erie and Niagara county residents.
The first follow-up to the baseline study took place between 2001 and 2004 and involved 1,455 of the original participants, all of whom had no known heart or kidney disease. Information on health indicators were collected once again. Analysis determined that 91 people who had normal glucose levels in 1996 had developed pre-diabetes since then.

Levels of cystatin C then were measured in the blood samples taken at baseline of these 91 and were compared to cystatin C levels in samples from 273 participants from the original cohort who had not developed pre-diabetes.

Results showed a direct link between those with the highest levels of cystatin C and the development of pre-diabetes, said Donahue. The association didn’t change when factors that traditionally are related to development of diabetes such as weight, amount of blood glucose at baseline, smoking history, high blood pressure or alcohol use were considered, he noted.

“Pre-clinical signs of renal impairment may occur before or coincident with pre-diabetes,” Donahue said. “These findings may suggest that those who have pre-diabetes also should be screened for early signs of kidney impairment, which itself is a major chronic illnes