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Massachusetts General Hospital and Joslin Diabetes Center participating in national study to identify best treatment for type 2 diabetes in youth

BOSTON - March 15, 2004 - Massachusetts General Hospital and Joslin Diabetes Center will be among the 12 medical centers and affiliates nationwide participating in a National Institutes of Health funded clinical study comparing three treatments of type 2 diabetes in children and teens. The study was announced today by HHS Secretary Tommy G. Thompson.

"Researchers have learned a great deal about treating type 2 diabetes in adults, but much less is known about how best to treat this increasingly common form of diabetes in youth," Secretary Thompson said. "This study will answer urgent questions about which therapy is most effective for the early stage of type 2 diabetes in young people."

The TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) study is the first clinical trial sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), one of the National Institutes of Health (NIH) under the Department of Health and Human Services, to focus on type 2 diabetes in youth.

"Formerly considered a disease of middle-aged and older adults, type 2 diabetes is increasingly occurring in children and young people. This study will provide us with new insights into the most effective ways to treat these patients," said Lori M. Laffel, M.D., M.P.H., chief of the pediatric and adolescent section at Joslin Diabetes Center in Boston. Dr. Laffel, assistant professor of Pediatrics at Harvard Medical School, is co-principal investigator for the Boston part of the study.

"The diabetes epidemic, with more than 800,000 new cases per year in the US, is now affecting all segments of the population, including children. Effective therapy is critical, since children will have this devastating disease for a lifetime," said David M. Nathan, MD, the principal investigator of the TODAY study in Boston. Dr. Nathan is director of the MGH Diabetes Center and a professor of Medicine at Harvard Medical School.

About 18.2 million people-6.3 percent of the U.S. population-have diabetes. It is the main cause of kidney failure, limb amputations, and new-onset blindness in adults and is a major cause of heart disease and stroke. Type 2 diabetes, most common in adults over age 40, accounts for up to 95 percent of all diabetes cases. The prevalence of type 2 diabetes has risen dramatically in the last 30 years. In the last 10 years alone, the prevalence of diagnosed diabetes cases increased 50 percent, due mostly to the upsurge in obesity.

Type 2 diabetes in both adults and children is closely linked to being overweight, inactive, and having a family history of diabetes. According to the 1999 to 2000 National Health and Nutrition Examination Survey, 15 percent of young people ages 6 to 19 are overweight - nearly triple the 1980 rate. Genetic susceptibility as well as lack of physical activity and unhealthy eating patterns all play important roles in determining a child's weight, the risk for type 2 diabetes, and other complications of being overweight.

About the Study
Participants in the TODAY study will be randomly assigned to one of three treatment groups: metformin alone, metformin and rosiglitazone in a fixed dose combination, and metformin plus intensive lifestyle change aimed at losing weight and increasing physical activity. Researchers plan to enroll 750 children and teens 10 to 17 years old diagnosed with type 2 diabetes in the past 2 years. The trial is expected to last five years.

The main goal is to determine how well and for how long each treatment approach controls blood glucose levels. The study will also evaluate the safety of the treatments; the effects of the treatments on insulin production, insulin resistance (a hallmark of type 2 diabetes in which cells do not effectively use insulin), body composition, nutrition, physical activity and aerobic fitness, risk factors for eye, kidney, nerve, and heart disease, quality of life, and psychological outcomes; the influence of individual and family behaviors on treatment response; and the cost-effectiveness of the treatments.

Many drugs are available to treat type 2 diabetes in adults, but metformin, which lowers the liver's production of glucose, is the only oral drug approved by the Food and Drug Administration to treat type 2 diabetes in children. Rosiglitazone, the other oral medicine used in the TODAY study, belongs to a class of insulin-sensitizing drugs called the thiazolidinediones (TZDs). It helps fat, muscle, and liver cells respond to insulin and use glucose more efficiently.

The American Diabetes Association is providing additional support for the study, which is also supported in part by LifeScan, GlaxoSmithKline, and Eli Lilly and Company.

For information about participating in the study at MGH, contact Barbara Steiner at 866 223-8644 (toll-free) or 617 724-5985. For Joslin participation, contact Nicole Sweatman at 800 322-6323 (toll-free), 617 732-2603 or send e-mail to TODAY@joslin.harvard.edu.

Additional information on TODAY study.

Media Contacts: Julie Bergan, MGH Public Affairs
Marge Dwyer, Joslin Public Affairs

MGH Physician Referral Service: 1-800-388-4644
Information about Clinical Trials