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The Today Study Will Identify Best Treatment For Type 2 Diabetes In Youth

Posted: Saturday, April 10, 2004

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. 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.

"Type 2 diabetes has increasingly become a problem in our young people," said NIH Director Elias A. Zerhouni. "This trial will give us the information we need to most effectively help these patients." Participants 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 5 years.

The TODAY study's 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;
*** the cost-effectiveness of the treatments.

TODAY is the first clinical study to look at the effects of intensive lifestyle change aimed at lowering weight by cutting calories and increasing physical activity in youths with type 2 diabetes.

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 (NHANES), 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.

The TODAY trial is one of two NIDDK-funded studies that will focus on type 2 diabetes in children. An upcoming prevention study will seek to develop cost-effective interventions that can be widely applied in schools across the country.