PMID- 36273149
OWN - NLM
STAT- MEDLINE
DCOM- 20221027
LR  - 20221027
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 23
IP  - 1
DP  - 2022 Oct 22
TI  - 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).
PG  - 900
LID - 10.1186/s13063-022-06762-3 [doi]
LID - 900
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.
CI  - (c) 2022. The Author(s).
FAU - van Rijswijk, A
AU  - van Rijswijk A
AUID- ORCID: 0000-0002-8086-3265
AD  - Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the 
      Netherlands.
FAU - van Olst, N
AU  - van Olst N
AD  - Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the 
      Netherlands.
AD  - Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
FAU - Meijnikman, A S
AU  - Meijnikman AS
AD  - Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
AD  - Department of Internal Medicine, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, 
      Hoofddorp, the Netherlands.
FAU - Acherman, Y I Z
AU  - Acherman YIZ
AD  - Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the 
      Netherlands.
FAU - Bruin, S C
AU  - Bruin SC
AD  - Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the 
      Netherlands.
FAU - van de Laar, A W
AU  - van de Laar AW
AD  - Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the 
      Netherlands.
FAU - van Olden, C C
AU  - van Olden CC
AD  - Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
FAU - Aydin, O
AU  - Aydin O
AD  - Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
AD  - Department of Internal Medicine, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, 
      Hoofddorp, the Netherlands.
FAU - Borger, H
AU  - Borger H
AD  - Department of Internal Medicine, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, 
      Hoofddorp, the Netherlands.
FAU - Beuers, U H W
AU  - Beuers UHW
AD  - Department of Gastroenterology and Hepatology and Tytgat Institute for Liver and 
      Intestinal Research, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the 
      Netherlands.
FAU - Herrema, H
AU  - Herrema H
AD  - Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
FAU - Verheij, J
AU  - Verheij J
AD  - Department of Pathology, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the 
      Netherlands.
FAU - Apers, J A
AU  - Apers JA
AD  - Department of Surgery, Franciscus Gasthuis, Kleiweg 500, 3045 PM, Rotterdam, the 
      Netherlands.
FAU - Backhed, F
AU  - Backhed F
AD  - Wallenberg Laboratory, Department of Molecular and Clinical Medicine, University 
      of Gothenburg, SE-413 45, Gothenburg, Sweden.
AD  - Novo Nordisk Foundation Center for Basic Metabolic Research, University of 
      Copenhagen, Blegdamsvej 3B, Building 7, DK-2200, Copenhagen, Denmark.
FAU - Gerdes, V E A
AU  - Gerdes VEA
AD  - Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
AD  - Department of Internal Medicine, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, 
      Hoofddorp, the Netherlands.
AD  - Department of Internal Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
FAU - Nieuwdorp, M
AU  - Nieuwdorp M
AD  - Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
AD  - Wallenberg Laboratory, Department of Molecular and Clinical Medicine, University 
      of Gothenburg, SE-413 45, Gothenburg, Sweden.
AD  - Department of Internal Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
AD  - Institute for Cardiovascular research, Amsterdam UMC, Meibergdreef 9, 1105 AZ, 
      Amsterdam, the Netherlands.
FAU - de Brauw, L M
AU  - de Brauw LM
AD  - Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the 
      Netherlands. mdebrauw@spaarnegasthuis.nl.
LA  - eng
SI  - ClinicalTrials.gov/NCT03330756
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20221022
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Bile Acids and Salts)
RN  - 0 (Blood Glucose)
SB  - IM
MH  - Humans
MH  - Bile Acids and Salts
MH  - Blood Glucose/metabolism
MH  - *Diabetes Mellitus, Type 2/complications/surgery
MH  - *Gastric Bypass/adverse effects/methods
MH  - Glycemic Control
MH  - Laparoscopy
MH  - Multicenter Studies as Topic
MH  - *Obesity, Morbid/surgery
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
PMC - PMC9588204
OTO - NOTNLM
OT  - Metabolic outcome
OT  - One-anastomosis gastric bypass
OT  - Randomized controlled trial
OT  - Roux-en-Y gastric bypass
OT  - Type 2 diabetes mellitus
COIS- 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.
EDAT- 2022/10/24 06:00
MHDA- 2022/10/26 06:00
PMCR- 2022/10/22
CRDT- 2022/10/23 00:16
PHST- 2022/05/04 00:00 [received]
PHST- 2022/09/16 00:00 [accepted]
PHST- 2022/10/23 00:16 [entrez]
PHST- 2022/10/24 06:00 [pubmed]
PHST- 2022/10/26 06:00 [medline]
PHST- 2022/10/22 00:00 [pmc-release]
AID - 10.1186/s13063-022-06762-3 [pii]
AID - 6762 [pii]
AID - 10.1186/s13063-022-06762-3 [doi]
PST - epublish
SO  - Trials. 2022 Oct 22;23(1):900. doi: 10.1186/s13063-022-06762-3.