Researchers at Childrens Hospital Los Angeles will lead a nationwide study backed by the National Institutes of Health to find the best treatment for type 2 diabetes in children and teens.
Francine R. Kaufman, professor of pediatrics at the Keck School of Medicine of USC, heads the project, called the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. It is the first clinical trial sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases to focus on type 2 diabetes in young people.
Health and Human Services Secretary Tommy Thompson announced the study March 15. “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,” 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.”
To conduct the study, physicians and scientists at 12 medical centers and affiliated sites will enroll 750 children and teenagers diagnosed with type 2 diabetes within the last two years. Mitchell Geffner, professor of pediatrics at the Keck School of Medicine, is principal investigator of the study site at Childrens Hospital Los Angeles.
Researchers will compare three treatment regimens to see which appears to control blood sugar levels best in kids and teens.
The study comes at a time of great change in the face of type 2 diabetes, Kaufman said.
“What was once a disease of our grandparents is now a disease of our children,” said Kaufman, director of the Comprehensive Childhood Diabetes Center at CHLA, where type 2 diabetes accounts for more than one in five new childhood diabetes cases.
“The lifestyle of our children has radically changed in the past 20 years, and especially in the past five years. Today, only one in four children in California is physically fit,” Kaufman 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,” she said.
Participants will be randomly assigned to one of three treatment groups. One will only use metformin, known by the brand name Glucophage. Another group will use metformin and rosiglitazone, known by the brand name Avandia. The third will use metformin while undergoing intensive lifestyle change aimed at losing weight and increasing physical activity. The trial is expected to last five years.
Besides determining how well and for how long each treatment controls blood glucose levels, the study also will 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 and psychological outcomes;
• The influence of individual and family behaviors on treatment response; and
• The cost-effectiveness of the treatments.
Many drugs are available to treat type 2 diabetes in adults, but metformin is the only oral drug approved by the United States Food and Drug Administration to treat type 2 diabetes in children. 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 thiazolidinediones. It helps muscle cells respond to insulin and use glucose more efficiently.
Once seen only in adults, type 2 diabetes has been rising steadily in all children, especially African Americans, Latinos and Native Americans, according to reports from clinics around the country.
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 1999-2000 National Health and Nutrition Examination Survey, 15 percent of people ages 6 to 19 are overweight—nearly triple the proportion in 1980.
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 American Diabetes Association provides additional support for the study, which also is supported in part by LifeScan, GlaxoSmithKline and Eli Lilly and Co.
For more information about the TODAY trial, call (323) 671-6052, or see www.TODAYstudy.org.