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The Today Study Will Identify Best Treatment For
Type 2 Diabetes In Youth
posted 04/10/04
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.
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.
Source: Diabetes In Control.com: NIH/NIDDK.
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