The effects of laparoscopic Roux-en-Y gastric bypass and one-anastomosis gastric bypass on glycemic control and remission of type 2 diabetes mellitus: study protocol for a multi-center randomized controlled trial (the DIABAR-trial)

Abstract

Background Metabolic surgery induces rapid remission of type 2 diabetes mellitus (T2DM). There is a paucity of high level evidence comparing the efficacy of the laparoscopic Roux-en-Y gastric bypass (RYGB) and the laparoscopic one-anastomosis gastric bypass (OAGB) in glycemic control. Also, the mechanisms that drive the conversion of T2DM in severe obese subjects to euglycemia are poorly understood. Methods The DIABAR-trial is an open, multi-center, randomized controlled clinical trial with 10 years follow-up which will be performed in 220 severely obese patients, diagnosed with T2DM and treated with glucose-lowering agents. Patients will be randomized in a 1:1 ratio to undergo RYGB or OAGB. The primary outcome is glycemic control at 12 months follow-up. Secondary outcome measures are diverse and include weight loss, surgical complications, psychologic status and quality of life, dietary behavior, gastrointestinal symptoms, repetitive bloodwork to identify changes over time, glucose tolerance and insulin sensitivity as measured by mixed meal tests, remission of T2DM, presence of non-alcoholic fatty liver disease/non-alcoholic steatohepatitis in liver biopsy, oral and fecal microbiome, cardiovascular performance, composition of bile acids, and the tendency to develop gallstones. Discussion The DIABAR-trial is one of the few randomized controlled trials primarily aimed to evaluate the glycemic response after the RYGB and OAGB in severe obese patients diagnosed with T2DM. Secondary aims of the trial are to contribute to a deeper understanding of the mechanisms that drive the remission of T2DM in severe obese patients by identification of microbial, immunological, and metabolic markers for metabolic response and to compare complications and side effects of RYGB and OAGB. Trial registration ClinicalTrials.gov NCT03330756; date first registered: October 13, 2017.

Differences in Psychological Health and Weight Loss after Bariatric Metabolic Surgery between Patients with and without Pain Syndromes

“…This study involves data from two ongoing prospective research projects, namely the BARIA- and DIABAR- studies [ 31 , 32 ]. Both studies were approved by the by the Medical Research Ethics Committee of the Academic Medical Center Amsterdam (approval code NL55755.018.15 and NL61882.048.17), and conducted in accordance with the Declaration of Helsinki and the Medical Research Involving Human Subjects Act (WMO).…”

“…Given that pain and obesity influence each other reciprocally, and that pain amelioration is associated with better psychological wellbeing, we hypothesized patients with a pain syndrome to experience greater improvements in their psychological wellbeing after bariatric metabolic surgery than patients without pain with the same weight loss results. Using recent data from the BARIA and DIABAR studies [ 31 , 32 ], we set out to evaluate whether weight loss leads to more pronounced improvements in depressive symptoms, health-related quality of life, self-esteem, self-efficacy to exercise, physical activity, self-efficacy to control eating behaviours and food cravings among patients with a pain syndrome compared to those without a pain syndrome.…”

Attachment style and post-bariatric surgery health behaviours: the mediating role of self-esteem and health self-efficacy

“…More details of the BARIA-study are described in a protocol paper [ 55 ]. The Diabar- project follows the same design and procedures as the BARIA study, with the exception that only patients with diabetes are eligible to participate [ 56 ]. Both studies were approved by the Medical Research Ethics Committee of the Academic Medical Center Amsterdam (approval codes: NL55755.018.15 and NL61882.048.17) prior to commencing the study, and conducted in accordance with the Declaration of Helsinki and the Medical Research Involving Human Subjects Act (WMO).…”