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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 BMJ+Open
2017 ; 7
(11
): e018598
Nephropedia Template TP
gab.com Text
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English Wikipedia
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
#MMPMID29146657
Glaysher MA
; Mohanaruban A
; Prechtl CG
; Goldstone AP
; Miras AD
; Lord J
; Chhina N
; Falaschetti E
; Johnson NA
; Al-Najim W
; Smith C
; Li JV
; Patel M
; Ahmed AR
; Moore M
; Poulter N
; Bloom S
; Darzi A
; Le Roux C
; Byrne JP
; Teare JP
BMJ Open
2017[Nov]; 7
(11
): e018598
PMID29146657
show ga
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/m(2) 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.