The University of Southampton
Medicine

Research project: EndoBarrier TM Gastrointestinal Liner Diabetes Trial

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Obesity is a modern pandemic which the World Health Organisation (WHO) has predicted by 2015 will cause 2.3 billion adults worldwide to be overweight (Body Mass Index (BMI) 25 -30 Kg/m2) and 700 million adults to be obese ( BMI > 30 Kg/m2). One of the major complications of obesity is diabetes. Diabetes UK estimate that 2.6 million people in the UK suffer from diabetes with 95% of these having type 2 diabetes (adult-onset diabetes).

Project Overview

Medical therapy to control diabetes is disappointing. Medical therapy alone with coaching on lifestyle modification with exercise and reduced energy intake produces after 2 years an average of only 4.3% of excess body weight loss and a maximum of only 13% achieve remission of diabetes, usually far less.

Improved blood sugar control after gastric bypass surgery occurs within days of surgery before significant weight loss suggesting that the improvement is related to the surgery. Following surgery, 41% of patients achieve remission with an HbA1c below 6%. Despite its undoubted efficacy, few operations are performed. In the UK only 3,600 were performed in 2009. Patients are understandably fearful of surgery despite the good outcomes.

In an attempt to avoid surgery a new device and concept has been developed called a duodenal - jejunal sleeve bypass (Endobarrier). This is a removable sleeve like device that is implanted inside part of the intestine and prevents food from being absorbed through the wall of that part of the intestine.

We propose to randomize obese patients with a BMI of >30 and type 2 diabetes to either best available medical therapy or the Endobarrier for a period of a year. Both groups will receive lifestyle coaching from dieticians and a personal trainer. The Endobarrier will be removed from patients after a year and they will be followed up for a further year to identify whether any benefits are maintained after removal of the device. The primary outcome we will look at will be the proportion of patients in each group that achieve improvement in/resolution of their diabetes using measures defined by the International Diabetes Federation. Secondary outcomes will be the proportion of excess weight loss achieved and the frequency of adverse effects with the Endobarrier.

Patients will be recruited from the Diabetes Research Networks at two locations in London and Southampton and through the Imperial Weight Loss Centre. We have engaged the primary care leads at the two sites to identify the patient population and from the initial surveys the numbers of patients that meet the inclusion criteria is very large (98,000 in North West London and 1% of all practice lists in Southampton) so that we will start by circulating 10 -20 practices in each region to identify willing participants.

To understand how the Endobarrier works we will perform a number of scientific studies on the patient samples we collect including looking at gut hormones, insulin sensitivity, brain activation studies using functional MRI scans and gut bacterial studies.

Please visit the Endobarrier website.

Local Investigator: Professor Michael Moore
Funder: NIHR - Efficacy and Mechanism Evaluation (EME) programme

Contact: mvm198@soton.ac.uk

 

Acknowledgement:

 

This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership.

Disclaimer:

The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NHS, NIHR or the Department of Health.

 

 

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