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For Immediate Release

Children's Hospital of Pittsburgh Part of National NIH Effort To Identify Best Treatments for Type 2 Diabetes in Youth

Increasingly children are developing adult diseases from being overweight

Children's Hospital of Pittsburgh has been chosen to be a part of a national effort to study type 2 diabetes in youth - a disease that was primarily seen in adults only.

A clinical study comparing three treatments of type 2 diabetes in children/teens has begun in 12 medical centers around the country, HHS Secretary Tommy Thompson announced today.

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 (HHS), to focus on type 2 diabetes in youth.

"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."

Type 2 diabetes in both adults and children is closely linked to being overweight, inactive and having a family history of diabetes. Once seen only in adults, type 2 diabetes has been rising steadily in children, especially minority adolescents - African-Americans, Hispanic-Americans, and American-Indians. According to the 1999 to 2000 National Health and Nutrition Examination Survey, 15 percent of young people ages 6 to 19 are overweight, nearly triple the 1980 rate.

"Children's Hospital of Pittsburgh is helping to find the answers to early diagnosis, treatment and prevention of type 2 diabetes in children," said Silva Arslanian, MD, an endocrinologist at Children's who is leading the study. "Type 2 diabetes is a rapidly growing problem in children that needs to be addressed now. We need to find effective treatment strategies in these children to prevent serious complications at an early age. We also need to develop prevention strategies that encourage healthy eating and active lifestyles in our children to stop the development of devastating adult diseases at such an early age."

Dr. Arlsanian's research in childhood insulin resistance and racial differences has helped advance this field of investigation in pediatrics. She is performing studies that go from the clinic to the research bench and back again to understand the origins of the complications of diabetes in children and to try to proactively diminish their incidence and impact.

Genetic susceptibility, as well as lack of physical activity and unhealthy eating patterns, play an important role in determining a child's weight, risk for type 2 diabetes, and other complications of being overweight.

In the last 10 years alone, the prevalence of diagnosed diabetes cases has increased more than 10 fold, due mostly to the upsurge in obesity.

The TODAY trial 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 TODAY study's main goal is to determine how well and for how long each treatment approach controls blood glucose levels. The study also will evaluate things such as the safety of the treatments, the effects of the treatments; cost-effectiveness of treatments, and the influence of individual and family behaviors on treatment response.

Participants will be assigned randomly to one of three treatment groups: metformin alone; metformin and rosiglitazone in 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 two years. The trial is expected to last five years.

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 muscle cells respond to insulin and use glucose more efficiently.

The American Diabetes Association is providing additional support for the study, which is also supported in part by LifeScan, GlaxoSmithKline, and Eli Lilly and Company.

For more information about type 2 diabetes visit Children's Hospital of Pittsburgh's Web site at www.chp.edu. For more information about the study, call Children's Hospital at 412-692-5928 or e-mail TODAY@chp.edu. More information about the study also is available by visiting www.TODAYstudy.org.

Contacts:
Marc Lukasiak, 412-692-5016, Marc.Lukasiak@chp.edu
Melanie Finnigan, 412-692-5016, Melanie.Finnigan@chp.edu

Last Update
February 18, 2014
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Last Update
February 18, 2014
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