A van Rijswijk1, N van Olst1,2, A S Meijnikman2,3, Y I Z Acherman1, S C Bruin1, A W van de Laar1, C C van Olden2, O Aydin2,3, H Borger3, U H W Beuers4, H Herrema2, J Verheij5, J A Apers6, F Bäckhed7,8, V E A Gerdes2,3,9, M Nieuwdorp2,7,9,10, L M de Brauw11. 1. Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands. 2. Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. 3. Department of Internal Medicine, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands. 4. Department of Gastroenterology and Hepatology and Tytgat Institute for Liver and Intestinal Research, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. 5. Department of Pathology, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. 6. Department of Surgery, Franciscus Gasthuis, Kleiweg 500, 3045 PM, Rotterdam, the Netherlands. 7. Wallenberg Laboratory, Department of Molecular and Clinical Medicine, University of Gothenburg, SE-413 45, Gothenburg, Sweden. 8. Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Blegdamsvej 3B, Building 7, DK-2200, Copenhagen, Denmark. 9. Department of Internal Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. 10. Institute for Cardiovascular research, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. 11. Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands. mdebrauw@spaarnegasthuis.nl.
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.
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.
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