STUDIES TO TREAT OR PREVENT PEDIATRIC TYPE 2 DIABETES (STOPP-T2D)
Principal Investigator: Kimberly Drews, Ph.D.
There is a growing concern among health care researchers and providers over the steady and pernicious increase in detection of type 2 diabetes in youth both in the US and abroad. Knowing the consequences of type 2 diabetes in adults for micro- and macro-vascular disease progression, and knowing the impact of adequate treatment and management on those consequences, medical science seeks to broaden the scope of research to include this under-investigated and growing population of patients. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has sponsored STOPP-T2D, a collaborative group of experts in the treatment and prevention of diabetes in children and adolescents. The collaborative group is engaged in two research efforts: (1) a randomized clinical trial of treatment for adolescents already diagnosed with type 2 diabetes and (2) a primary prevention trial designed to prevent the development of risk factors for type 2 diabetes in middle school age youth.
TODAY (Treatment Options for type 2 Diabetes in Adolescents & Youth) is conducted at 15 clinical centers. A total of 704 children and adolescents are enrolled and randomized to one of three treatment arms: (1) metformin alone, (2) metformin plus rosiglitazone, and (3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program (TLP). Participants are followed a minimum of 2 years.
HEALTHY was conducted in 42 middle schools at 7 field centers. Schools were randomized to either the intervention or control. The intervention is a multi-disciplinary effort designed to change the school nutrition environment, related to food and beverage quality and availability, and the physical activity environment, related to physical education class activities and involvement. In addition, educational and promotional programs and campaigns target healthy behaviors and awareness. A cohort of students was recruited in 6th grade and followed through the end of 8th grade. Six pilot and feasibility studies were conducted preparatory to the full scale trial.
Funded by NIH/NIDDK Cooperative Agreement U01-DK061230, 2001-2012.)