A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

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Abstract

DESCRIPTION (provided by applicant): This application requests funds to continue longer-term follow up of outcomes and investigate maintenance of weight in a previously funded comparative effectiveness clinical trial (NIH# RC1DK086037) comparing surgical and medical treatments for Type 2 diabetes in lower BMI subjects. The initial study is the first successfully completed randomized feasibility and early outcomes trial to compare gastric bypass, gastric banding, and a structured weight loss program induced by diet and increased physical activity for the treatment of Type 2 diabetes mellitus (T2DM) in moderately obese patients with BMIs between 30 and 40 kg/m2. The primary aim of this proposal is to continue longer-term follow up of outcomes in a unique cohort of 60 total randomized subjects with Class I and II obesity that underwent intervention in one of three arms; gastric bypass, gastric banding, and a structured weight loss program. The outcomes of interest are measured at one year follow-up in the originally funded study, and will be extended to subsequent annual visits over 3 years. These measures include evaluation of diabetes resolution, change in metabolic parameters, body composition, physical activity, and several psychosocial measures. A secondary aim is to investigate the feasibility and importance of the initiation of a structured low level lifestyle intervention administered to all three treatment groups on weight maintenance over the longer-term follow up. Finally, longer-term data from this extension of the first randomized cohort of its type will fill an important knowledge gap and guide future studies.