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)

A van Rijswijk, N van Olst, A S Meijnikman, Y I Z Acherman, S C Bruin, A W van de Laar, C C van Olden, O Aydin, H Borger, U H W Beuers, H Herrema, J Verheij, J A Apers, F Bäckhed, V E A Gerdes, M Nieuwdorp, L M de Brauw, A van Rijswijk, N van Olst, A S Meijnikman, Y I Z Acherman, S C Bruin, A W van de Laar, C C van Olden, O Aydin, H Borger, U H W Beuers, H Herrema, J Verheij, J A Apers, F Bäckhed, V E A Gerdes, M Nieuwdorp, L M de Brauw

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.

Keywords: Metabolic outcome; One-anastomosis gastric bypass; Randomized controlled trial; Roux-en-Y gastric bypass; Type 2 diabetes mellitus.

Conflict of interest statement

F.B. is a founder and in the Scientific Advisory Board of MetaboGen AB, Sweden. M.N. is the founder and in the Scientific Advisory Board of Caelus Pharmaceuticals, the Netherlands. None of these are directly relevant to the current paper. The remaining authors declare that they have no conflict of interest.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Outline of study enrolment, randomization, intervention and follow-up. FG Franciscus Gasthuis, FU follow-up, MMT mixed meal test, M month, OAGB one-anastomosis gastric bypass, RYGB Roux-en-Y gastric bypass, SG Spaarne Gasthuis, t time, W week
Fig. 2
Fig. 2
Roux-en-Y gastric bypass
Fig. 3
Fig. 3
One-anastomosis gastric bypass

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