A clinical study comparing three treatments of type 2 diabetes in children and teens has begun in 12 medical centers and their affiliated sites around the country, HHS Secretary Tommy G. Thompson announced.
"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.
"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.
"What was once a disease of our grandparents is now a disease of our children," said study chair Dr. Francine Kaufman, director of the Comprehensive Childhood Diabetes Center at the Childrens Hospital Los Angeles, where type 2 diabetes accounts for more than 20 per cent of new childhood diabetes cases. "The lifestyle of our children has radically changed in the past 20 years, and especially in the past 5 years. Today, only one in four children in California is physically fit," she noted, citing a recent California Department of Education study.
The longer a person has diabetes, the greater the chances of developing serious damage to the eyes, nerves, heart, kidneys, and blood vessels. "Yet we're seeing kids in their late teens who are already developing the complications of type 2 diabetes," noted Dr. Kaufman.