• Aruchuna Ruban, Alexander D Miras, Michael A Glaysher, Anthony P Goldstone, Christina G Prechtl, Nicholas Johnson, Navpreet Chhina, Werd Al-Najim, Madhawi Aldhwayan, Natalia Klimowska-Nassar, Claire Smith, Joanne Lord, Jia V Li, Lilliam Flores, Moaz Al-Lababidi, Georgios K Dimitriadis, Mayank Patel, Michael Moore, Harvinder Chahal, Ahmed R Ahmed, Jonathan Cousins, Ghadah Aldubaikhi, Ben Glover, Emanuela Falaschetti, Hutan Ashrafian, RouxCarel W leCWLDiabetes Complications Research Center, University College Dublin, Ireland., Ara Darzi, James P Byrne, and Julian P Teare.
• Department of Surgery and Cancer, Imperial College, London, UK.
• Ann. Surg. 2022 Mar 1; 275 (3): 440447440-447.

ObjectiveThe 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 DataThis 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.MethodsIn 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.ResultsThere 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.ConclusionsThe 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 RegistrationISRCTN30845205. isrctn.org; Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership reference 12/10/04.Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

17 keywords...

hide…