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A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus

A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus
A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus

Introduction: The prevalence of obesity and obesity-related diseases, including type 2 diabetes mellitus (T2DM), is increasing. Exclusion of the foregut, as occurs in Roux-en-Y gastric bypass, has a key role in the metabolic improvements that occur following bariatric surgery, which are independent of weight loss. Endoscopically placed duodenal-jejunal bypass sleeve devices, such as the EndoBarrier (GI Dynamics, Lexington, Massachusetts, USA), have been designed to create an impermeable barrier between chyme exiting the stomach and the mucosa of the duodenum and proximal jejunum. The non-surgical and reversible nature of these devices represents an attractive therapeutic option for patients with obesity and T2DM by potentially improving glycaemic control and reducing their weight.


Methods and analysis: In this multicentre, randomised, controlled, non-blinded trial, male and female patients aged 18–65 years with a body mass index 30–50 kg/m2 and inadequately controlled T2DM on oral antihyperglycaemic medications (glycosylated haemoglobin (HbA1c) 58–97 mmol/mol) will be randomised in a 1:1 ratio to receive either the EndoBarrier device (n=80) for 12 months or conventional medical therapy, diet and exercise (n=80). The primary outcome measure will be a reduction in HbA1c by 20% at 12 months. Secondary outcome measures will include percentage weight loss, change in cardiovascular risk factors and medications, quality of life, cost, quality-adjusted life years accrued and adverse events. Three additional subgroups will investigate the mechanisms behind the effect of the EndoBarrier device, looking at changes in gut hormones, metabolites, bile acids, microbiome, food hedonics and preferences, taste, brain reward system responses to food, eating and addictive behaviours, body fat content, insulin sensitivity, and intestinal tissue gene expression.

Trial registration number: ISRCTN30845205, ClinicalTrials.gov Identifier NCT02459561.
2044-6055
Glaysher, Michael Alan
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Mohanaruban, Arunchuna
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Prechtl, Christina Gabriele
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Goldstone, Anthony P.
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Miras, Alexander Dimitri
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Lord, Joanne
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Chhina, Navpreet
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Falaschetti, Emanuela
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Johnson, Nicholas Andrew
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Al-Najim, Werd
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Smith, Claire
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Li, Jia V.
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Patel, Mayank
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Ahmed, Ahmed R.
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Moore, Michael
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Poulter, Neil
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Bloom, Stephen
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Darzi, Ara
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Le Roux, Carel
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Byrne, James P.
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Teare, Julian P.
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Glaysher, Michael Alan
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Mohanaruban, Arunchuna
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Prechtl, Christina Gabriele
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Goldstone, Anthony P.
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Miras, Alexander Dimitri
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Lord, Joanne
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Chhina, Navpreet
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Falaschetti, Emanuela
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Johnson, Nicholas Andrew
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Al-Najim, Werd
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Smith, Claire
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Li, Jia V.
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Patel, Mayank
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Ahmed, Ahmed R.
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Moore, Michael
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Poulter, Neil
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Bloom, Stephen
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Darzi, Ara
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Le Roux, Carel
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Byrne, James P.
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Teare, Julian P.
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Glaysher, Michael Alan, Mohanaruban, Arunchuna, Prechtl, Christina Gabriele, Goldstone, Anthony P., Miras, Alexander Dimitri, Lord, Joanne, Chhina, Navpreet, Falaschetti, Emanuela, Johnson, Nicholas Andrew, Al-Najim, Werd, Smith, Claire, Li, Jia V., Patel, Mayank, Ahmed, Ahmed R., Moore, Michael, Poulter, Neil, Bloom, Stephen, Darzi, Ara, Le Roux, Carel, Byrne, James P. and Teare, Julian P. (2017) A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus. BMJ Open, 7 (11), [e018598]. (doi:10.1136/bmjopen-2017-018598).

Record type: Article

Abstract


Introduction: The prevalence of obesity and obesity-related diseases, including type 2 diabetes mellitus (T2DM), is increasing. Exclusion of the foregut, as occurs in Roux-en-Y gastric bypass, has a key role in the metabolic improvements that occur following bariatric surgery, which are independent of weight loss. Endoscopically placed duodenal-jejunal bypass sleeve devices, such as the EndoBarrier (GI Dynamics, Lexington, Massachusetts, USA), have been designed to create an impermeable barrier between chyme exiting the stomach and the mucosa of the duodenum and proximal jejunum. The non-surgical and reversible nature of these devices represents an attractive therapeutic option for patients with obesity and T2DM by potentially improving glycaemic control and reducing their weight.


Methods and analysis: In this multicentre, randomised, controlled, non-blinded trial, male and female patients aged 18–65 years with a body mass index 30–50 kg/m2 and inadequately controlled T2DM on oral antihyperglycaemic medications (glycosylated haemoglobin (HbA1c) 58–97 mmol/mol) will be randomised in a 1:1 ratio to receive either the EndoBarrier device (n=80) for 12 months or conventional medical therapy, diet and exercise (n=80). The primary outcome measure will be a reduction in HbA1c by 20% at 12 months. Secondary outcome measures will include percentage weight loss, change in cardiovascular risk factors and medications, quality of life, cost, quality-adjusted life years accrued and adverse events. Three additional subgroups will investigate the mechanisms behind the effect of the EndoBarrier device, looking at changes in gut hormones, metabolites, bile acids, microbiome, food hedonics and preferences, taste, brain reward system responses to food, eating and addictive behaviours, body fat content, insulin sensitivity, and intestinal tissue gene expression.

Trial registration number: ISRCTN30845205, ClinicalTrials.gov Identifier NCT02459561.

Text
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More information

Accepted/In Press date: 22 September 2017
e-pub ahead of print date: 15 November 2017
Published date: November 2017

Identifiers

Local EPrints ID: 416236
URI: http://eprints.soton.ac.uk/id/eprint/416236
ISSN: 2044-6055
PURE UUID: bcb2aecb-5efc-49ce-9df7-a20ab5a1e2a3
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

Catalogue record

Date deposited: 08 Dec 2017 17:30
Last modified: 22 Nov 2021 02:52

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Contributors

Author: Michael Alan Glaysher
Author: Arunchuna Mohanaruban
Author: Christina Gabriele Prechtl
Author: Anthony P. Goldstone
Author: Alexander Dimitri Miras
Author: Joanne Lord
Author: Navpreet Chhina
Author: Emanuela Falaschetti
Author: Nicholas Andrew Johnson
Author: Werd Al-Najim
Author: Claire Smith
Author: Jia V. Li
Author: Mayank Patel
Author: Ahmed R. Ahmed
Author: Michael Moore ORCID iD
Author: Neil Poulter
Author: Stephen Bloom
Author: Ara Darzi
Author: Carel Le Roux
Author: James P. Byrne
Author: Julian P. Teare

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