Treatment TODAY

NIH trial first to focus on childhood diabetes

Once a disease of our grandparents, type 2 diabetes is becoming increasingly common in children.

While researchers have learned a great deal about how to treat type 2 diabetes in adults, much less is known about the best way to treat children with the disease.

The School of Medicine is among 12 U.S. sites to participate in the first clinical trial to focus on type 2 diabetes in children and teens.

Neil White, M.D., director of the division of pediatric endocrinology and metabolism, sees 16-year-old diabetes patient Aaron Van Landuit for routine follow-up care.
Neil White, M.D., director of the division of pediatric endocrinology and metabolism, sees 16-year-old diabetes patient Aaron Van Landuit for routine follow-up care.

The multicenter study is called the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study and is sponsored by the National Institutes of Health.

“Type 2 diabetes historically was not a health problem for children,” said St. Louis principal investigator Neil H. White, M.D., director of the division of pediatric endocrinology and meta-bolism.

“However, as our children have become more sedentary and overweight over the last five years, we’ve seen them develop type 2 diabetes.”

According to a recent National Health and Nutrition Examination Survey, 15 percent of young people ages 6-19 are overweight — nearly triple the rate in 1980.

Type 2 diabetes is closely linked to being overweight, lack of physical activity, unhealthy eating patterns and a family history of the disease.

TODAY is the first clinical study to look at the effects of intensive lifestyle changes aimed at lowering weight by cutting calories and increasing physical activity in youths with type 2 diabetes.

“Finding effective therapies to treat children who have type 2 diabetes as early as possible is critical to delay the complications of the disease,” White said.

“The longer a person has diabetes, the greater the chances he or she will seriously damage the eyes, nerves, heart, kidneys and blood vessels. We’re seeing kids in their late teens who already are developing complications of type 2 diabetes.”

The study will compare the effectiveness and safety of three treatment approaches to control blood glucose levels: the use of metformin, the current first-line drug therapy; metformin combined with another drug called rosiglitazone; and metformin combined with intensive lifestyle changes.

“While doctors know how to treat type 2 diabetes in adults, they can’t assume those therapies will work as well and as safely in children and teens,” White 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 ages 10-17 who have been diagnosed with type 2 diabetes in the past two years for the five-year study. Saint Louis University also is one of the U.S. sites.

More than 18.2 million people in the United States have diabetes, and up to 95 percent of those cases are attributed to type 2. 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.

Once exclusively considered an adult disease, type 2 diabetes is rising among all children — especially African-American, Hispanic and Native American adolescents.

While some people have no symptoms, others experience fatigue, nausea, frequent urination, unusual thirst, blurred vision, frequent infections and slow healing of wounds and sores.

The disease in children is usually diagnosed in adolescence during mid-to-late puberty, but may manifest earlier as children become more and more overweight.

“Obesity and type 2 diabetes are among the most serious health challenges facing America’s youth today,” said co-investigator Sherida Tollefsen, M.D., director of pediatric endocrinology at SLU.

“We need to do all we can to develop strategies that encourage healthy eating and active lifestyles in our children.”

Study participants will receive free diabetes supplies, medications and care from a team of diabetes experts.

For more information or to volunteer for the trial, call (877) 785-2329 or go online to todaystudy.org.

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