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).

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.

Long-term Emergency Department Visits and Readmissions After Laparoscopic Roux-en-Y Gastric Bypass: a Systematic Review.

PURPOSE: There is considerable evidence on short-term outcomes after laparoscopic Roux-en-Y gastric bypass (LRYGB), but data on long-term outcome is scarce, especially on postoperative emergency department (ED) visits and readmissions. We aim to systematically review evidence on the incidence, indications, and risk factors of ED visits and readmissions beyond 30 days after LRYGB. MATERIALS AND METHODS: A systematic search in PubMed, Scopus, Embase.com , Cochrane Library, and PsycINFO was performed. All studies reporting ED visits and readmissions > 30 days after LRYGB, with ≥ 50 patients, were included. PRISMA statement was used and the Newcastle-Ottawa Scale for quality assessment. RESULTS: Twenty articles were included. Six studies reported on ED visits (n = 2818) and 19 on readmissions (n = 276,543). The rate of patients with an ED visit within 90 days after surgery ranged from 3.9 to 32.6%. ED visits at 1, 2, and 3 years occurred in 25.6%, 30.0%, and 31.1% of patients. Readmissions within 90 days and at 1-year follow-up ranged from 4.1 to 20.5% and 4.75 to 16.6%, respectively. Readmission was 29% at 2 years and 23.9% at 4.2 years of follow-up. The most common reason for ED visits and readmissions was abdominal pain. CONCLUSION: Emergency department visits and readmissions have been reported in up to almost one in three patients on the long-term after LRYGB. Both are mainly indicated for abdominal pain. The report on indications and risk factors is very concise. A better understanding of ED visits and readmissions after LRYGB is warranted to improve long-term care, in particular for patients with abdominal pains.

A systems biology approach to understand gut microbiota and host metabolism in morbid obesity: design of the BARIA Longitudinal Cohort Study.

INTRODUCTION: Prevalence of obesity and associated diseases, including type 2 diabetes mellitus, dyslipidaemia and non-alcoholic fatty liver disease (NAFLD), are increasing. Underlying mechanisms, especially in humans, are unclear. Bariatric surgery provides the unique opportunity to obtain biopsies and portal vein blood-samples. METHODS: The BARIA Study aims to assess how microbiota and their metabolites affect transcription in key tissues and clinical outcome in obese subjects and how baseline anthropometric and metabolic characteristics determine weight loss and glucose homeostasis after bariatric surgery. We phenotype patients undergoing bariatric surgery (predominantly laparoscopic Roux-en-Y gastric bypass), before weight loss, with biometrics, dietary and psychological questionnaires, mixed meal test (MMT) and collect fecal-samples and intra-operative biopsies from liver, adipose tissues and jejunum. We aim to include 1500 patients. A subset (approximately 25%) will undergo intra-operative portal vein blood-sampling. Fecal-samples are analyzed with shotgun metagenomics and targeted metabolomics, fasted and postprandial plasma-samples are subjected to metabolomics, and RNA is extracted from the tissues for RNAseq-analyses. Data will be integrated using state-of-the-art neuronal networks and metabolic modeling. Patient follow-up will be ten years. RESULTS: Preoperative MMT of 170 patients were analysed and clear differences were observed in glucose homeostasis between individuals. Repeated MMT in 10 patients showed satisfactory intra-individual reproducibility, with differences in plasma glucose, insulin and triglycerides within 20% of the mean difference. CONCLUSION: The BARIA study can add more understanding in how gut-microbiota affect metabolism, especially with regard to obesity, glucose metabolism and NAFLD. Identification of key factors may provide diagnostic and therapeutic leads to control the obesity-associated disease epidemic.