The Children's Hospital of Philadelphia Studies Best Treatment of Type 2 Diabetes in Children and Teens

03/15/2004

PHILADELPHIA, March 15 /PRNewswire/ -- As type 2 diabetes continues its increase at alarming rates among children, clinicians and researchers from The
Children's Hospital of Philadelphia are participating in a new multicenter,
multi-year study comparing three different treatment options for children
affected with type 2 diabetes.

"Increasing numbers of children today are diagnosed with type 2 diabetes, a disease that was formerly known as one that affected adults, not children," said Charles Stanley, M.D., chief of Endocrinology and primary investigator of
the study at The Children's Hospital of Philadelphia. "Ten years ago, approximately two children were diagnosed with type 2 diabetes each year at Children's Hospital. Last year almost 70 children received that diagnosis."

The TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) study is the first clinical trial sponsored by the National Institutes of Health to focus on children affected with type 2 diabetes. Participants will be randomly assigned to one of three treatment groups: metformin alone, metformin and rosiglitazone, and metformin plus intensive lifestyle change aimed at losing weight and increasing physical activity. Nationally, researchers plan to enroll 750 children and adolescents diagnosed with type 2 diabetes in the past two years. Of that total, Children's Hospital plans to
enroll 75 children. The trial is expected to last five years.

The study's main goal is to determine how well, and for how long, each treatment controls blood glucose levels. The study will also evaluate the safety of the treatments; the effects of the treatments on insulin production, insulin resistance, body composition, nutrition, physical activity and aerobic fitness; risk factors for eye, kidney, nerve, and heart disease; quality of life; psychological outcomes; the influence of individual and family behaviors on treatment response; and cost-effectiveness of the treatments.

The longer a person has diabetes, the greater the chances of developing serious damage to the eyes, nerves, heart, kidneys and blood vessels. "We're seeing teenagers that are already developing the complications of type 2
diabetes," said Lorraine Katz, M.D., pediatric endocrinologist and co-
investigator at Children's Hospital. "It's critical to provide the safest, most effective therapy as early as possible in order to delay the complications of the disease, and we can't assume that therapies used in adults will work as well and as safely in children and teens."

Many medications are available to treat type 2 diabetes in adults, but metformin is the only oral medicine currently approved by the Food and Drug
Administration to treat type 2 diabetes in children. Considered first-line therapy by most pediatric endocrinologists, it works by lowering the liver's production of glucose. 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.

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 children with type 2 diabetes.

"Many children and teens today consume large amounts of calories from unhealthy foods and lead sedentary lifestyles," said Robert Berkowitz, M.D., chief of Psychiatry at The Children's Hospital of Philadelphia and a trial investigator at this site. "The family-based lifestyle modification component of this trial includes introducing healthier eating habits and increased physical activity as a possible alternative treatment for type 2 diabetes."

Once seen only in adults, type 2 diabetes has been rising steadily in all children, especially minority adolescents - African Americans, Hispanic Americans, and American Indians. Childhood type 2 diabetes cases have risen dramatically since 1994, when less than 5 percent of new childhood diabetes cases were type 2. By 1999, type 2 diabetes accounted for 8 to 45 percent of new childhood diabetes cases, depending on geographic location.

About 18.2 million people - 6.3 percent of the U.S. population - have diabetes. It is the main cause of kidney failure, limb amputations, and new-onset blindness in adults, and is a major cause of heart disease and stroke. Type 2 diabetes, most common in adults over age 40, accounts for up to 95 percent of all diabetes cases. The prevalence of type 2 diabetes has risen dramatically in the last 30 years. In the last 10 years alone, the prevalence of diagnosed diabetes cases increased 50 percent, due mostly to the upsurge in obesity.

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 further information, interested families should call the Children's
Hospital trial recruitment coordinator at 215.590.5127.

Founded in 1855 as the nation's first pediatric hospital, The Children's Hospital of Philadelphia is ranked in 2003 as the best pediatric hospital in the nation by U.S. News & World Report and Child magazines. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking second in National Institutes of Health funding among children's hospitals. In addition, its unique family-centered care and public service programs have brought the 430-bed hospital recognition as a leading advocate for children and adolescents from before birth through age 19. Children's Hospital operates the largest pediatric healthcare system in the U.S. with more than 40 locations in Pennsylvania, New Jersey and
Delaware.

Contact: Joey Marie McCool
Phone: (267) 426-6070
McCool@email.chop.edu