Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial.

Autor:	Ruban A; Department of Surgery and Cancer, Imperial College, London, UK., Miras AD; Department of Metabolism, Digestion and Reproduction, Imperial College, London, UK., Glaysher MA; Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Goldstone AP; PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith Hospital, London, UK., Prechtl CG; Imperial College London, Department of Public Health, Imperial Clinical Trials Unit, London, UK., Johnson N; Imperial College London, Department of Public Health, Imperial Clinical Trials Unit, London, UK., Chhina N; PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith Hospital, London, UK., Al-Najim W; Diabetes Complications Research Center, University College Dublin, Ireland., Aldhwayan M; Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia., Klimowska-Nassar N; Imperial College London, Department of Public Health, Imperial Clinical Trials Unit, London, UK., Smith C; Imperial College London, Department of Public Health, Imperial Clinical Trials Unit, London, UK., Lord J; Southampton Health Technology Assessment Center, University of Southampton, Southampton, UK., Li JV; Section of Nutritional research, Department of Metabolism, Digestion and Reproduction, Imperial College London, UK., Flores L; PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith Hospital, London, UK., Al-Lababidi M; PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith Hospital, London, UK., Dimitriadis GK; Department of Endocrinology, King's College Hospital NHS Trust, London, UK., Patel M; University Hospital Southampton NHS Foundation Trust, Biomedical Research Center, Southampton, UK., Moore M; Primary Care, Population Sciences and Medical Education, University of Southampton Medical School, Southampton, UK., Chahal H; Department of Metabolism, Digestion and Reproduction, Imperial College, London, UK., Ahmed AR; Department of Surgery and Cancer, Imperial College, London, UK., Cousins J; Department of Surgery and Cancer, Imperial College, London, UK., Aldubaikhi G; PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith Hospital, London, UK., Glover B; Department of Surgery and Cancer, Imperial College, London, UK., Falaschetti E; Imperial College London, Department of Public Health, Imperial Clinical Trials Unit, London, UK., Ashrafian H; Department of Surgery and Cancer, Imperial College, London, UK., Roux CWL; Diabetes Complications Research Center, University College Dublin, Ireland., Darzi A; Department of Surgery and Cancer, Imperial College, London, UK., Byrne JP; Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Teare JP; Department of Surgery and Cancer, Imperial College, London, UK.
Jazyk:	angličtina
Zdroj:	Annals of surgery [Ann Surg] 2022 Mar 01; Vol. 275 (3), pp. 440-447.
DOI:	10.1097/SLA.0000000000004980
Abstrakt:	Objective: The aim of this study was to examine the clinical efficacy and safety of the duodenal-jejunal bypass liner (DJBL) while in situ for 12 months and for 12 months after explantation. Summary Background Data: This is the largest randomized controlled trial (RCT) of the DJBL, a medical device used for the treatment of people with type 2 diabetes mellitus (T2DM) and obesity. Endoscopic interventions have been developed as potential alternatives to those not eligible or fearful of the risks of metabolic surgery. Methods: In this multicenter open-label RCT, 170 adults with inadequately controlled T2DM and obesity were randomized to intensive medical care with or without the DJBL. Primary outcome was the percentage of participants achieving a glycated hemoglobin reduction of ≥20% at 12 months. Secondary outcomes included weight loss and cardiometabolic risk factors at 12 and 24 months. Results: There were no significant differences in the percentage of patients achieving the primary outcome between both groups at 12 months [DJBL 54.6% (n = 30) vs control 55.2% (n = 32); odds ratio (OR) 0.93, 95% confidence interval (CI): 0.44-2.0; P = 0.85]. Twenty-four percent (n = 16) patients achieved ≥15% weight loss in the DJBL group compared to 4% (n = 2) in the controls at 12 months (OR 8.3, 95% CI: 1.8-39; P = .007). The DJBL group experienced superior reductions in systolic blood pressure, serum cholesterol, and alanine transaminase at 12 months. There were more adverse events in the DJBL group. Conclusions: The addition of the DJBL to intensive medical care was associated with superior weight loss, improvements in cardiometabolic risk factors, and fatty liver disease markers, but not glycemia, only while the device was in situ. The benefits of the devices need to be balanced against the higher rate of adverse events when making clinical decisions. Trial Registration: ISRCTN30845205. isrctn.org; Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership reference 12/10/04. Competing Interests: Declaration of interests: A.R. received travel fees support from GI Dynamics. A.D.M. has received honoraria for presentations and advisory board contribution by Novo Nordisk, Boehringer Ingelheim, AstraZeneca, Johnson & Johnson and research grant funding from Fractyl. A.P.G. reports funding supported by UK Medical Research Council and Wellcome Trust, outside of the submitted work, is on a Data Safety Monitoring Board for Novo Nordisk, and has received honoraria for presentations and advisory board contribution by Janssen, Pfizer, Novo Nordisk, Zafgen, Soleno Therapeutics Inc, and Millendo Theapeutics Inc, and Merck. A.R.A. received educational grants from MSD and WL Gore. C.W.R. is a member of scientific advisory board for Herbalife, GI Dynamics, NovoNordisk, Keyron, Sanofi, has provided ad hoc consulting for Ethicon and Fractyl, occasional speaking engagement for MSD, Boehringer Ingelheim and Lilly. J.P.T. received travel fees support from GI Dynamics. The rest of the authors report no conflicts of interest. The authors report no conflict of interests. (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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