Yale One of 12 Centers Comparing Treatments for Type 2 Diabetes in Youth

A clinical study comparing three treatments of type 2 diabetes in children and teens has begun at Yale and 11 other medical centers and their affiliated sites around the country.

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. It is also the first to look at the effects of intensive lifestyle change aimed at lowering weight by cutting calories and increasing physical activity in young people with type 2 diabetes.

The principal investigator at the Yale Center is Sonia Caprio, M.D., associate professor of pediatric endocrinology at Yale School of Medicine, associate clinical professor at the Yale School of Nursing and attending pediatric endocrinologist at the Yale-New Haven Children’s Hospital.

Many drugs are available to treat type 2 diabetes in adults. 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. It helps fat, muscle, and liver cells respond to insulin and use glucose more efficiently.

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 fitness and risk factors for disease. It will also evaluate quality of life and psychological outcomes, the influence of individual and family behaviors on treatment response, and the cost-effectiveness of the treatments.

“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,” Health and Human Services Secretary Tommy G. 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.”

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.

“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.”

Another NIDDK-funded prevention study will seek to develop cost-effective interventions that can be widely applied in schools across the country.

The TODAY study chair is Francine R. Kaufman, M.D., at Children’s Hospital of Los Angeles. The coordinating center is at George Washington University and the study centers include University of Colorado Health Sciences Center, Massachusetts General Hospital, Washington University School of Medicine and the Saint Louis University School of Medicine, State University of New York Upstate Medical University, Case Western Reserve University School of Medicine, University of Oklahoma Health Sciences Center, The ChildrenÕs Hospital of Philadelphia, ChildrenÕs Hospital of Pittsburg, Baylor College of Medicine, and University of Texas Health Science Center at San Antonio.

The study is supported by the American Diabetes Association LifeScan, GlaxoSmithKline, and Eli Lilly and Company.

For more information about the Yale trial, please call Cindy Guandalini at 203-764-6652. To learn more about the national study, please contact Joan Chamberlain or Jane DeMouy at NIDDK, 301-496-3583 or visit the TODAY Study Q&A (http://www.niddk.nih.gov/patient/TODAY/QA.htm) and the study’s web site at www.TODAYstudy.org