This study design is a parallel-randomized intervention trial of African-American youth with type 2 diabetes who are not on insulin therapy and who are within 3 years of diagnosis. Patients aged 12-21 years with type 2 diabetes will be enrolled. Participants will be randomized into two intervention arms (16 in each group): metformin and liraglutide versus metformin alone. The study will consist of 5 visits. At Visit 1, a medical history, physical examination and screening labs will be done. Eligible participants will undergo a one-week drug-free run-in. At Visit 2 there will be an overnight inpatient stay to perform metabolic testing prior to starting the study drug(s). Participants will start the study drug(s) immediately after Visit 2 and remain on the study drug(s) for 12 weeks. Follow-up monitoring will be performed at 4 week intervals (Visit 3 and 4). The final visit (Visit 5) will occur after 12 weeks. This study received the NIH Clinical Center Bench-to-Bedside Award in 2016 and is a collaboration between Childrens National Medical Center and NIDDK, NIH. We have received IRB approval at both institutions and have a contractual reliance agreement to facilitate information sharing and data collection. Two participants have enrolled since June 2017 and several ongoing and planned outreach strategies are in place to support study recruitment.
| Hall, Kevin D; Chung, Stephanie T (2018) Low-carbohydrate diets for the treatment of obesity and type 2 diabetes. Curr Opin Clin Nutr Metab Care 21:308-312 |
| Chung, Stephanie T; Hsia, Daniel S; Chacko, Shaji K et al. (2015) Increased gluconeogenesis in youth with newly diagnosed type 2 diabetes. Diabetologia 58:596-603 |
