Imperial College London
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MrNicholasJohnson

Faculty of Medicine, School of Public Health

Research Fellow
 
 
 
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Contact

 

+44 (0)20 7594 1751nicholas.johnson

 
 
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Location

 

Stadium HouseWhite City Campus

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Summary

 

Publications

Citation

BibTex format

@article{Ruban:2020:10.3310/eme07060,
author = {Ruban, A and Glaysher, MA and Miras, AD and Goldstone, AP and Prechtl, CG and Johnson, N and Li, J and Aldhwayan, M and Aldubaikhi, G and Glover, B and Lord, J and Onyimadu, O and Falaschetti, E and Klimowska-Nassar, N and Ashrafian, H and Byrne, J and Teare, JP},
doi = {10.3310/eme07060},
journal = {Efficacy and Mechanism Evaluation},
pages = {1--130},
title = {A duodenal sleeve bypass device added to intensive medical therapy for obesity with type 2 diabetes: a RCT},
url = {http://dx.doi.org/10.3310/eme07060},
volume = {7},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundThe EndoBarrier® (GI Dynamics Inc., Boston, MA, USA) is an endoluminal duodenal–jejunal bypass liner developed for the treatment of patients with obesity and type 2 diabetes mellitus. Meta-analyses of its effects on glycaemia and weight have called for larger randomised controlled trials with longer follow-up.ObjectivesThe primary objective was to compare intensive medical therapy with a duodenal–jejunal bypass liner with intensive medical therapy without a duodenal–jejunal bypass liner, comparing effectiveness on the metabolic state as defined by the International Diabetes Federation as a glycated haemoglobin level reduction of ≥ 20%. The secondary objectives were to compare intensive medical therapy with a duodenal–jejunal bypass liner with intensive medical therapy without a duodenal–jejunal bypass liner, comparing effectiveness on the metabolic state as defined by the International Diabetes Federation as a glycated haemoglobin level of < 42 mmol/mol, blood pressure of < 135/85 mmHg, and the effectiveness on total body weight loss. Additional secondary outcomes were to investigate the cost-effectiveness and mechanism of action of the effect of a duodenal–jejunal bypass liner on brain reward system responses, insulin sensitivity, eating behaviour and metabonomics.DesignA multicentre, open-label, randomised controlled trial.SettingImperial College Healthcare NHS Trust and University Hospital Southampton NHS Foundation Trust.ParticipantsPatients aged 18–65 years with a body mass index of 30–50 kg/m2 and with inadequately controlled type 2 diabetes mellitus who were on oral glucose-lowering medications.InterventionsParticipants were randomised equally to receive intensive medical therapy alongside a duodenal–jejunal bypass liner device (n = 85) or intensive medical therapy alone for 12 months (n = 85), and were followed up
AU  - Ruban,A
AU  - Glaysher,MA
AU  - Miras,AD
AU  - Goldstone,AP
AU  - Prechtl,CG
AU  - Johnson,N
AU  - Li,J
AU  - Aldhwayan,M
AU  - Aldubaikhi,G
AU  - Glover,B
AU  - Lord,J
AU  - Onyimadu,O
AU  - Falaschetti,E
AU  - Klimowska-Nassar,N
AU  - Ashrafian,H
AU  - Byrne,J
AU  - Teare,JP
DO  - 10.3310/eme07060
EP  - 130
PY  - 2020///
SN  - 2050-4365
SP  - 1
TI  - A duodenal sleeve bypass device added to intensive medical therapy for obesity with type 2 diabetes: a RCT
T2  - Efficacy and Mechanism Evaluation
UR  - http://dx.doi.org/10.3310/eme07060
UR  - https://www.journalslibrary.nihr.ac.uk/eme/eme07060#/abstract
UR  - http://hdl.handle.net/10044/1/84590
VL  - 7
ER  -
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