(2021) Duodenal-Jejunal bypass liner for the management of Type 2 Diabetes mellitus and obesity - a multicenter randomized controlled trial. Annals of Surgery . doi:10.1097/SLA.0000000000004980 (In Press)

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Abstract

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.

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine R Medicine > RD Surgery
Divisions:	Faculty of Medicine > Warwick Medical School > Biomedical Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Jejunoileal bypass, Gastric bypass, Non-insulin-dependent diabetes -- Treatment, Obesity -- Surgery
Journal or Publication Title:	Annals of Surgery
Publisher:	Lippincott Williams & Wilkins
ISSN:	0003-4932
Official Date:	14 June 2021
Dates:	Date Event 14 June 2021 Available 9 June 2021 Accepted
DOI:	10.1097/SLA.0000000000004980
Status:	Peer Reviewed
Publication Status:	In Press
Access rights to Published version:	Restricted or Subscription Access
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID UNSPECIFIED Fractyl Health UNSPECIFIED UNSPECIFIED [MRC] Medical Research Council http://dx.doi.org/10.13039/501100000265 UNSPECIFIED Wellcome Trust http://dx.doi.org/10.13039/100010269
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