March 2004 - 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:
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- 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 percent 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.
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 fat, muscle, and liver 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 youths with type 2 diabetes. The NIDDK-sponsored LookAHEAD trial is currently studying the benefits of weight loss in adults with type 2 diabetes.
Once seen only in adults, type 2 diabetes has been rising steadily in all children, especially African American, Hispanic American and American Indian adolescents, according to reports from clinics around the country. Studies in Cincinnati, Charleston, Los Angeles, San Antonio, and other cities report that 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. Some diabetes centers are now seeing more new cases of type 2 diabetes than type 1 diabetes, an autoimmune disease.
"African American, Hispanic American and American Indian children are at greatest risk for type 2 diabetes," noted Dr. Zerhouni. "This study reflects the strong NIH commitment to help eliminate health disparities that affect minority populations and the medically underserved."
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. "Obesity and type 2 diabetes are among the most serious health challenges facing America's youth today," said Secretary Thompson. "We need to do all we can to develop strategies that encourage healthy eating and active lifestyles in our children."
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.
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Type 1 diabetes, which affects up to 1 million people in the United States, develops when the body's immune system destroys the insulin-producing beta cells of the pancreas. Type 1 diabetes usually strikes children and young adults, who need several insulin injections a day or an insulin pump to survive.
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. To learn more about the study, call a participating center (visit http://www.niddk.nih.gov/patient/today/centers.htm). See also the TODAY Study Q&A at http://www.niddk.nih.gov/patient/TODAY/QA.htm and the study's web site at www.TODAYstudy.org.