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.

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.

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. The NIDDK-sponsored LookAHEAD trial is currently studying the benefits of weight loss in adults 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. "Obesity and type 2 diabetes are among the most serious health challenges facing America's youth today," said Secretary Thompson. "We need to do all we can to develop strategies that encourage healthy eating and active lifestyles in our children."

To learn more about the study, call a participating center (http://www.niddk.nih.gov/patient/today/centers.htm). See also the TODAY Study Q&A (http://www.niddk.nih.gov/patient/TODAY/QA.htm) and the study's web site at www.TODAYstudy.org.