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UK EndoBarrier study

UK surgeons assess EndoBarrier to treat T2DM

Researchers are looking for volunteers living with diabetes to take part in a research study, who are aged 18 to 65 years, living with type 2 diabetes and have a BMI30-50

UK surgeons from Southampton General Hospital and Imperial College Healthcare NHS Trust, London, have begun a 24-month study that will examine whether EndoBarrier Therapy is more effective at treating type 2 diabetes than medication, diet and exercise. The study, which will recruit 160 participants, will compare EndoBarrier with standard medical therapy for the management of obese people with type 2 diabetes.

Professor Julian Teare

“Type 2 diabetes affects millions of people in the UK and many of these people have been unsuccessful at managing their diabetes with their current treatment regimens,” said Professor Julian Teare, a consultant gastroenterologist and study lead based at Imperial College London. “While previous clinical trials and commercial experience suggest that EndoBarrier therapy is a safe and effective treatment option for type 2 diabetes, results from this study should provide definitive evidence to help guide treatment decisions. The use of a lower cost and less invasive alternative to bypass surgery may mean we can treat thousands more people living with type 2 diabetes every year.”

The procedure, which was trialled on adult patients in a pilot study at Southampton General Hospital and two other NHS sites in 2011, is performed under a short general anaesthetic and sees patients return home within two to three hours. Results of that study showed a drop in blood glucose levels within weeks of receiving the implant, reducing the need for diabetes medication, while patients also achieved significant weight loss similar to that seen following gastric band surgery.

Mr James Byrne

“We know weight loss surgery is currently the most effective and longest-lasting treatment option for type 2 diabetes,” added Mr James Byrne, a consultant surgeon and co-lead based at Southampton General. “However, it is not the right approach for everyone and will not significantly impact the epidemic of type 2 diabetes we see in the UK. Other strategies for this condition are urgently required and our research will confirm whether or not EndoBarrier therapy can help to deliver and, more importantly, sustain improvements in diabetes control.”

Recruitment

Researchers are looking for volunteers living with diabetes to take part in a research study, who are aged 18 to 65 years, living with type 2 diabetes and have a BMI30-50. If you're interested in taking part in this study, please contact the researchers using the details below to arrange a screening visit to determine if you are eligible for the study.

If you are able to take part, you will 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).

You will then be informed about the treatment you will receive during the study, including any tests that will be performed. A dietitian will also assess your diet and give you specific dietary information and guidance.

Depending on which group you are in, a few weeks later you will either received the EndoBarrier device (EndoBarrier group) or you will see the diabetic specialist doctor or nurse (medical therapy group).

During some of your visits, the researchers 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. Travel expenses to and from the hospital will be provided.

If you are interested in taking part in the study please contact:

Southampton EndoBarrier research team
Email: endobarriernurses@uhs.nhs.uk
Telephone: 023 8120 8591
Mobile: 07917 085362

The study is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership.

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