An analysis of the results of a study of bariatric surgery and a separate trial of medical therapy in treating type 2 diabetes in teenagers with severe obesity shows that after two years of treatment, body mass index (BMI) and HbA1c, a measure of blood sugar control, are both significantly better with surgery.
The results were presented Sunday, June 12 at the annual meeting of the American Diabetes Association in New Orleans.
"Compared to medical management, surgical treatment of severely obese adolescents resulted in better glycemic control but was associated with a higher rate of subsequent hospitalization over the initial two-year treatment period," says Thomas Inge, MD, PhD, lead author of the analysis. Dr. Inge is surgical director of the Surgical Weight Loss Program for Teens and director of the Center for Bariatric Research and Innovation at Cincinnati Children's Hospital Medical Center.
These results were seen in a secondary analysis of data previously collected in two prospective multicenter studies. Thirty adolescents with type 2 diabetes who underwent surgical treatment for severe obesity had been enrolled into the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study. Teen-LABS was conducted by investigators at five clinical centers in the U.S. These surgically treated patients were compared to 63 teens - matched as closely as possible for age, gender, race/ ethnicity-- selected from the 699 teens who received medical intervention in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY). TODAY is a randomized clinical trial that compared the efficacy and safety of medical treatment strategies for adolescents and youth with type 2 diabetes. TODAY was conducted at 15 centers in the U.S. Teen-LABS and TODAY were funded by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health.
Regardless of what medication was used to treat the diabetes, HbA1c increased over time among participants in the TODAY study, while it declined among surgical participants. BMI was 54 kg/m2 in the Teen-LABS participants and 41 kg/m2 in the TODAY participants at baseline. Participants in the TODAY trial had a 3.5 percent increase in BMI two years after starting medical treatment, while the BMI of those in the Teen-LABS study decreased by 28 percent two years after surgery. Although attempts were made to match subjects from Teen-LABS to those in the TODAY study, there may have been other important differences between the participants in the two studies that could have affected the results of this analysis.
Five percent of TODAY participants required hospitalization within two years of treatment while 33 percent of Teen-LABS participants required hospitalization within two years. "While the complications documented in this study are typical of those seen in patients undergoing complex gastrointestinal surgery, they suggest that the treatment benefits have to be weighed realistically with the risks," said Inge.
Dr. Lori Laffel, a pediatric endocrinologist at the Joslin Diabetes Center and Professor of Pediatrics at Harvard Medical School in Boston, MA, and an investigator with the TODAY study group notes that, "These data are unique and point to a need to more carefully study the role of surgery in the treatment of adolescents affected by type 2 diabetes due to the favorable impact on both BM I and glycemic control." After the two years, more than 2.5 times more participants in Teen-LABS achieved excellent glycemic control with HbA1c levels of <6.5% than participants in the TODAY study. "Additional research with longer follow-up is needed," added Laffel.
Cincinnati Children's Hospital Medical Center