Imperial College London
Alternate

Dr Tony Goldstone

Faculty of Medicine, Department of Brain Sciences

Reader in PsychoNeuroEndocrinology
 
 
 
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Contact

 

+44 (0)20 7594 5989tony.goldstone Website

 
 
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Location

 

S25Commonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Ruban:2022:10.1097/SLA.0000000000004980,
author = {Ruban, A and Miras, A and glaysher, M and Goldstone, A and Teare, J},
doi = {10.1097/SLA.0000000000004980},
journal = {Annals of Surgery},
pages = {440--447},
title = {Duodenal-jejunal bypass liner for the management of Type 2 diabetes and obesity: a multicenter randomized controlled trial},
url = {http://dx.doi.org/10.1097/SLA.0000000000004980},
volume = {275},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - 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
AU  - Ruban,A
AU  - Miras,A
AU  - glaysher,M
AU  - Goldstone,A
AU  - Teare,J
DO  - 10.1097/SLA.0000000000004980
EP  - 447
PY  - 2022///
SN  - 0003-4932
SP  - 440
TI  - Duodenal-jejunal bypass liner for the management of Type 2 diabetes and obesity: a multicenter randomized controlled trial
T2  - Annals of Surgery
UR  - http://dx.doi.org/10.1097/SLA.0000000000004980
UR  - http://hdl.handle.net/10044/1/95008
VL  - 275
ER  -
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