New technology for managing type 2 diabetes - EndoBarrier study
No need for surgery
The new device – an EndoBarrier gastrointestinal liner – helps people with diabetes to manage their blood sugar levels and lose weight without the need for surgery.
This study will compare how effective the EndoBarrier device is, compared to current standard care to treat type 2 diabetes.
How it works
The EndoBarrier is a 60cm long impermeable sleeve-like device that is inserted stomach endoscopically and creates a thin plastic layer between food and the wall of the intestine. This could prevent food from coming into contact with the gut until further down the intestine and may reduce your level of hunger and fullness.
If you're interested in taking part in this study, please contact us using the details below to arrange a screening visit. Here, a doctor will do some tests to determine if you’re eligible for the study.
If you're able to take part, you'll be randomised to receive either the EndoBarrier device for 12 months and a set diet for a further 12 months (EndoBarrier group), or current standard care and a set diet for 24 months (medical therapy group).
We'll then invite you back to tell you about the treatment you will receive during the study, including any tests that will be performed whilst you’re taking part. A dietitian will also assess your diet and give you specific dietary information and guidance.
Depending on which group you’re in, you’ll come back in a few weeks to have the EndoBarrier device inserted (EndoBarrier group) or you'll see the diabetic specialist doctor or nurse (medical therapy group).
During some of your visits, we may also ask you to participate in tests to help us assess your metabolism, brain activity, insulin sensitivity and food preference – taking part in these tests is optional. You’ll also receive support from a diabetic specialist doctor or nurse, a dietitian and a gastroenterologist (EndoBarrier group only) throughout the study.
Further information about taking part can be found in the patient information sheet, including possible advantages and disadvantages of taking part.
Travel expenses to and from the hospital will be provided.
Southampton EndoBarrier research team
Telephone: 023 8120 8591
Mobile: 07917 085362
This trial is joint with Imperial College London, their contact details are:
Professor Julian Teare, chief investigator
Dr Christina Prechtl, study manager
This project is independent research funded by an Efficacy and Mechanism Evaluation award from the National Instittute for Health Research (NIHR) and Medical Research Council (MRC).
The views and opinions expressed therein are those of the author and do not necessarily reflect those of the NIHR, MRC, NHS or the Department of Health.