TY - JOUR
T1 - The effects of laparoscopic Roux-en-Y gastric bypass and one-anastomosis gastric bypass on glycemic control and remission of type 2 diabetes mellitus
T2 - study protocol for a multi-center randomized controlled trial (the DIABAR-trial)
AU - van Rijswijk, A.
AU - van Olst, N.
AU - Meijnikman, A. S.
AU - Acherman, Y. I. Z.
AU - Bruin, S. C.
AU - van de Laar, A. W.
AU - van Olden, C. C.
AU - Aydin, O.
AU - Borger, H.
AU - Beuers, U. H. W.
AU - Herrema, H.
AU - Verheij, J.
AU - Apers, J. A.
AU - Bäckhed, F.
AU - Gerdes, V. E. A.
AU - Nieuwdorp, M.
AU - de Brauw, L. M.
N1 - Funding Information: Financial support: The study reported here was additionally supported a Novo Nordisk Foundation Gut-MMM grant to M.N. and F.B.. M.N. is supported by a personal ZONMW-VIDI grant 2013 (016.146.327). F.B. is supported by Swedish Research Council, Swedish Diabetes Foundation, Swedish Heart Lung Foundation, Swedish Foundation for Strategic Research, Knut and Alice Wallenberg foundation, Göran Gustafsson Foundation, Ingbritt and Arne Lundberg’s foundation, Swedish Heart Lung Foundation, Torsten Söderberg’s Foundation, Ragnar Söderberg’s Foundation, NovoNordisk Foundation, AFA insurances, and LUA-ALF grants from Västra Götalandsregionen, and Stockholm County Council. F.B. is a recipient of ERC Consolidator Grant (European Research Council, Consolidator grant 615362—METABASE). Publisher Copyright: © 2022, The Author(s).
PY - 2022/12/1
Y1 - 2022/12/1
N2 - 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.
AB - 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.
KW - Bile Acids and Salts
KW - Blood Glucose/metabolism
KW - Diabetes Mellitus, Type 2/complications
KW - Gastric Bypass/adverse effects
KW - Glycemic Control
KW - Humans
KW - Laparoscopy
KW - Metabolic outcome
KW - Multicenter Studies as Topic
KW - Obesity, Morbid/surgery
KW - One-anastomosis gastric bypass
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Randomized controlled trial
KW - Roux-en-Y gastric bypass
KW - Treatment Outcome
KW - Type 2 diabetes mellitus
UR - http://www.scopus.com/inward/record.url?scp=85140346785&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-022-06762-3
DO - https://doi.org/10.1186/s13063-022-06762-3
M3 - Article
C2 - 36273149
SN - 1745-6215
VL - 23
SP - 900
JO - Trials
JF - Trials
IS - 1
M1 - 900
ER -