This is a 3-month randomized trial in youth with type 2 diabetes with 2 intervention arms (metformin alone and metformin and liraglutide). Protocol initiation was delayed because of several factors external to the study: (1) delays in funding availability (January May 2016), (2) interruption in stable isotope supply secondary to the closure of the NIH Pharmaceutical Development Service and challenges in NIH Pharmacy identifying stable a outsourcing 503b pharmaceutical service (November 2016 to May 2017), and (3) administrative delays in contractual reliance agreement between CNMC and NIH IRB (January 2017 to June 2017). Since recruitment began in July 2017, we have screened 25 participants of which 15 were enrolled: 4 completers, 4 on study, 4 withdrawn for medical reasons (meeting exclusion criteria) and 3 lost to follow-up. Of note, continued interruptions in stable isotope supply resulted in loss to follow-up of 2 enrolled participants in February and April 2018. Otherwise, study implementation has progressed without procedural issues and no participants have experienced any serious adverse events. The data safety and monitoring board has met twice (November 2017 and May 2018) and no safety or regulatory issues identified. Recruitment is continuing successfully and includes: mailing distribution of study fliers and posting bulletin boards at CNMC and The NIH Clinical Center, social media text and video postings on approved social media site, and the NIH website and newspaper advertisements. We continue to promote health literacy and research by partnering with community organizations including, Communities in Schools, The Naturalist Audobon Society, and the DC Community Advisory Board. In pursuing exploratory aims of the study, we have worked with collaborators to publish review articles on the state of the science of diabetes risk in youth with obesity (Chung et al. NY Acad Sci 2018) and potentially using alternative non-drug targets, such as low carbohydrate diets (Hall et al. Curr Diab Opin 2018). Ultimately, the randomized study should be allowed to continue because our findings will provide novel insight into pathophysiology of diabetes in youth, the drugs used to treat this chronic disease and pharmacogenomic targets.
| 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 |
