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Open Access 01-12-2022 | Diabetes | Study protocol

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)

Authors: 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

Published in: Trials | Issue 1/2022

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.

Available only for authorised users

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Title: 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)
Authors: 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
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Diabetes
Type 2 Diabetes
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06762-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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