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EndoBarrier study

First patient treated in UK's REVISE-Diabesity trial

Study is investigating mechanisms of action

The first patient has been treated with an EndoBarrier gastrointestinal liner as part of the Randomisation to Endobarrier alone Versus with Incretin analogue in SustainEd Diabesity (REVISE-Diabesity) clinical trial. The UK-based study, which is supported by the Association of British Clinical Diabetologists (ABCD), will include 72 patients studied over 24 months.

"This trial presents an exciting opportunity for patients with combined diabetes and weight problems, who currently have limited treatment options, to kick start their way back to health,” said lead researcher, Dr Piya Sen Gupta, ABCD Research Fellow. “It is a novel idea to use a device to treat diabesity when the usual medications have failed and it may offer a valuable treatment option, avoiding in some, the need for invasive bariatric surgery.”

REVISE-Diabesity is a multi-centre randomised controlled clinical trial involving liraglutide-treated patients with type 2 diabetes and obesity (HbA1c ≥7.5% [58mmol/mol], BMI ≥35).

The study is investigating mechanisms of action and their time course by repeated measures of: (1) glycated haemoglobin, weight, waist circumference and BMI; (2) fasting glucose, insulin, HOMA-IR; (3) hepatic and pancreatic triacylglycerol stores assessed by magnetic resonance imaging.

Patients will be randomised to receive either: 1. Control group: increase Liraglutide dose 1.2mg to 1.8mg 2. Endobarrier alone group: stop Liraglutide therapy, undergo Endobarrier insertion 3. Endobarrier+Liraglutide group: continue Liraglutide 1.2mg, undergo Endobarrier insertion.

"The twin epidemics of obesity and diabetes may bankrupt our healthcare systems, with the projected spend on diabetes rising from the current 10% of NHS expenditure to 17% of NHS expenditure by 2035 and it is estimated that, for type 2 diabetes, the cost of complications of the disease is more than threefold the cost of treatment,” said ABCD Chairman, Dr Chris Walton. “ABCD is keen to research new technologies that confront obesity in diabetes and which may prevent the relentless progress to complications, so the placement of the first endobarrier device in this study is a landmark date''

The trial is also examining whether maintaining treatment with a GLP-1 receptor agonist increases the impact both during and after EndoBarrier, compared to discontinuing the GLP1RA.

The EndoBarrier consists of a 60cm tube-like liner made from a thin, flexible and durable impermeable polymer. It is inserted by endoscopy and is anchored in place, just beyond the stomach, by a basket of very thin wire made of Nitinol-an alloy of nickel and titanium. The liner prevents food from contacting the first two feet of small intestine and, according to previous studies, can lead to considerable weight loss (18% reduction) and improvement in diabetes control (87% of patients reach the target control level).

The trial has been funded by a grant from the ABCD’s Diabetes Care Trust and is supported by the NHS and is centred at Birmingham's City Hospital with supporting centres in London (King's College Hospital and Guy's and St Thomas' Hospitals) and Glasgow (Glasgow Royal Infirmary).

“At the moment we have many patients who remain overweight and with poor diabetes control, despite all the available diabetes treatments,” said Dr Bob Ryder, Principal Investigator for the ABCD study. "Because the EndoBarrier reduces weight and improves the diabetes control, it is a treatment that could break the cycle of problems for these patients who have otherwise come to the end of the line. “

For more information on the ABCD endobarrier study click here

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