The TRIABETES – ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes

Description

The Specific Aims of the first phase of the study are as follows:

Aim 1. To determine the feasibility of performing a randomized trial comparing two major types of bariatric surgery, Laparoscopic Roux en Y Gastric Bypass (RNY) and Laparoscopic Adjustable Gastric Banding (GB) versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese patients (Class I and II obesity) with T2DM. We hypothesize that: 1) A randomized design with both surgical and non-surgical arms will be both feasible and acceptable to participants and to providers 2) There will be no difference in retention rates between the LWLI and surgical arms (RNY, GB) of the study and it will provide estimates of overall retention for future studies.

Aim 2. To obtain preliminary information regarding the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity. We hypothesize that: 1) RNY will be superior to GB and LWLI in weight lost in 12 months.

Aim 3. To explore the feasibility, methods for, and implementation of a range of early outcome measures including; resolution of diabetes, glucose control, medication usage, insulin resistance, beta cell function, body composition, objective measures of physical activity, and several psychosocial measures. We hypothesize that: 1) Participants will be willing to undergo a range of early outcome testing measures to assess metabolic change, body composition alterations, objective physical activity, and psychosocial factors. 2) Measures of T2DM improvement including an intravenous glucose tolerance test (IVGTT) will be feasible in a subset of participants in each study arm and RNY will be superior to both GB and LWLI for the clinical and metabolic improvement of T2DM. 3) The LWLI group will show improvements in physical activity compared to RNY and GB.