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Duodenal-jejunal bypass liner for the management of type 2 diabetes mellitus and obesity: A multicenter randomized controlled trial

Duodenal-jejunal bypass liner for the management of type 2 diabetes mellitus and obesity: A multicenter randomized controlled trial
Duodenal-jejunal bypass liner for the management of type 2 diabetes mellitus and obesity: A multicenter randomized controlled trial

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 of 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.

Adult, Diabetes Mellitus, Type 2/surgery, Duodenum/surgery, Female, Humans, Jejunoileal Bypass/adverse effects, Jejunum/surgery, Male, Middle Aged, Obesity/surgery, Treatment Outcome
0003-4932
440-447
Ruban, Aruchuna
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Miras, Alexander D
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Glaysher, Michael A
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Goldstone, Anthony P
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Prechtl, Christina G
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Johnson, Nicholas
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Chhina, Navpreet
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Al-Najim, Werd
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Aldhwayan, Madhawi
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Klimowska-Nassar, Natalia
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Smith, Claire
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Lord, Joanne
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Li, Jia V
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Flores, Lilliam
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Al-Lababidi, Moaz
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Patel, Mayank
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Moore, Michael
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Chahal, Harvinder
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Ahmed, Ahmed R
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Cousins, Jonathan
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Aldubaikhi, Ghadah
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Glover, Ben
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Falaschetti, Emanuela
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Ashrafian, Hutan
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Roux, Carel W le
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Darzi, Ara
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Byrne, James P
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Teare, Julian P
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Ruban, Aruchuna
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Miras, Alexander D
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Glaysher, Michael A
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Goldstone, Anthony P
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Prechtl, Christina G
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Johnson, Nicholas
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Chhina, Navpreet
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Al-Najim, Werd
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Aldhwayan, Madhawi
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Klimowska-Nassar, Natalia
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Smith, Claire
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Lord, Joanne
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Li, Jia V
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Flores, Lilliam
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Al-Lababidi, Moaz
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Dimitriadis, Georgios K
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Patel, Mayank
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Moore, Michael
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Chahal, Harvinder
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Ahmed, Ahmed R
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Cousins, Jonathan
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Aldubaikhi, Ghadah
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Glover, Ben
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Falaschetti, Emanuela
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Ashrafian, Hutan
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Roux, Carel W le
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Darzi, Ara
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Byrne, James P
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Teare, Julian P
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Ruban, Aruchuna, Miras, Alexander D, Glaysher, Michael A, Goldstone, Anthony P, Prechtl, Christina G, Johnson, Nicholas, Chhina, Navpreet, Al-Najim, Werd, Aldhwayan, Madhawi, Klimowska-Nassar, Natalia, Smith, Claire, Lord, Joanne, Li, Jia V, Flores, Lilliam, Al-Lababidi, Moaz, Dimitriadis, Georgios K, Patel, Mayank, Moore, Michael, Chahal, Harvinder, Ahmed, Ahmed R, Cousins, Jonathan, Aldubaikhi, Ghadah, Glover, Ben, Falaschetti, Emanuela, Ashrafian, Hutan, Roux, Carel W le, Darzi, Ara, Byrne, James P and Teare, Julian P (2022) Duodenal-jejunal bypass liner for the management of type 2 diabetes mellitus and obesity: A multicenter randomized controlled trial. Annals of Surgery, 275 (3), 440-447. (doi:10.1097/SLA.0000000000004980).

Record type: Article

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 of 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.

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e-pub ahead of print date: 15 June 2021
Published date: 1 March 2022
Additional Information: Funding Information: 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. Funding Information: This study was funded by the Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership reference 12/10/04. The devices and nutritional supplements were kindly provided free of charge by GI Dynamics and Nutricia Advanced Medical Nutrition respectively. Infrastructure support was provided by the NIHR Imperial Biomedical Research Center, NIHR Imperial and Clinical Research Facility, London, NIHR Southampton Biomedical Research Center UK and NIHR Southampton clinical research facility, Southampton, UK. The views expressed are those of the authors and not necessarily those of the UK National Health Service, the NIHR, or the UK Department of Health and Social Care. The Division of Diabetes, Endocrinology and Metabolism is funded by grants from the UK Medical Research Council (MRC), Biotechnology and Biological Sciences Research Council, and the NIHR; an Integrative Mammalian Biology Capacity Building Award; and an FP7- HEALTH-2009–241592 EuroCHIP grant. It is also supported by the NIHR Biomedical Research Center Funding Scheme. JVL is funded by a MRC New Investigator Grant 9MR/P002536/1) and ERC Starting Grant (715662) as well as supported by the NIHR Imperial Biomedical Research Center (BRC). Publisher Copyright: © 2022 Lippincott Williams and Wilkins. All rights reserved. Copyright: Copyright 2022 Elsevier B.V., All rights reserved.
Keywords: Adult, Diabetes Mellitus, Type 2/surgery, Duodenum/surgery, Female, Humans, Jejunoileal Bypass/adverse effects, Jejunum/surgery, Male, Middle Aged, Obesity/surgery, Treatment Outcome

Identifiers

Local EPrints ID: 455844
URI: http://eprints.soton.ac.uk/id/eprint/455844
ISSN: 0003-4932
PURE UUID: 42dcc29a-85e1-4a16-a9ae-a4dd51a19248
ORCID for Joanne Lord: ORCID iD orcid.org/0000-0003-1086-1624
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

Catalogue record

Date deposited: 06 Apr 2022 16:46
Last modified: 10 Jun 2022 01:43

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Contributors

Author: Aruchuna Ruban
Author: Alexander D Miras
Author: Michael A Glaysher
Author: Anthony P Goldstone
Author: Christina G Prechtl
Author: Nicholas Johnson
Author: Navpreet Chhina
Author: Werd Al-Najim
Author: Madhawi Aldhwayan
Author: Natalia Klimowska-Nassar
Author: Claire Smith
Author: Joanne Lord ORCID iD
Author: Jia V Li
Author: Lilliam Flores
Author: Moaz Al-Lababidi
Author: Georgios K Dimitriadis
Author: Mayank Patel
Author: Michael Moore ORCID iD
Author: Harvinder Chahal
Author: Ahmed R Ahmed
Author: Jonathan Cousins
Author: Ghadah Aldubaikhi
Author: Ben Glover
Author: Emanuela Falaschetti
Author: Hutan Ashrafian
Author: Carel W le Roux
Author: Ara Darzi
Author: James P Byrne
Author: Julian P Teare

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