CHOP Patients, Researchers Involved in Type 2 Diabetes Study
May 10, 2012 — Type 2 diabetes is especially challenging to treat in young people, and working to prevent the condition is more important than ever. That may be the biggest message from the recent large national clinical trial of treatments for type 2 diabetes in youths. Patients and staff members of the Diabetes Center for Children at The Children’s Hospital of Philadelphia were strongly involved in the federally funded multicenter study that announced its results on April 29.
“Type 2 diabetes progresses more rapidly in young people than in adults,” said pediatric endocrinologist Lorraine E. Levitt Katz, MD, adding that the disease may require more aggressive early treatment in young patients. Dr. Levitt Katz was the project leader at The Children’s Hospital of Philadelphia study center that joined the TODAY study, which stands for Treatment Options for Type 2 Diabetes in Adolescents and Youth. The National Institutes of Health funded TODAY, which enrolled nearly 700 patients aged 10 to 17 across the U.S. from 2004 to 2009. Sixty-nine patients participated from The Children’s Hospital of Philadelphia.
In type 2 diabetes, a patient produces insufficient insulin or becomes unable to properly use the insulin his or her body does produce. The result is an inability to control blood sugar. Although the disease has been increasing in recent years among young people, the best treatment for this population remains unknown. The TODAY study divided participants into 3 treatment groups. One group received only metformin, a pill that is the standard drug for young people with the disease. A second group took both metformin and another drug, rosiglitazone, also called Avandia. A third group took metformin and made lifestyle changes, such as healthier eating behaviors, keeping active and managing weight. Children and adolescents from diverse racial and ethnic background participated in 15 centers throughout the U.S.
The researchers evaluated how well participants were able to control their blood sugar. Overall, treatment succeeded in only 54 percent of the 699 participants. The treatment was effective in 53 percent of those in the group that combined metformin with lifestyle changes, compared to 48 percent success in those taking metformin without the lifestyle program, a difference that was not statistically significant. The group that combined both medications had 61 percent success, significantly better than taking metformin alone. However, rosiglitazone has been restricted in use since 2010 by the Food and Drug Administration because of heart problems reported in adult patients. None of the young people in the study’s treatment groups had serious side effects.
Dr. Levitt Katz and her colleagues at Children’s Hospital published a 2011 study in the Journal of Pediatrics showing that glycemic control in youths with type 2 diabetes declines as early as two years after diagnosis. Data from this study and from the TODAY study show that the disease progresses quickly in children and adolescents. TODAY study researchers will present their results in a symposium on June 9 at the 2012 Scientific Sessions of the American Diabetes Association in Philadelphia.
John Ascenzi, Children’s Hospital of Philadelphia, Phone: 267-426-6055, Ascenzi@email.chop.edu