What is the purpose of the study?
A new device called the EndoBarrier Gastrointestinal Liner helps patients with diabetes 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 standard medical care in the treatment of type 2 diabetes.
How does EndoBarrier work?
The EndoBarrier has been shown to help control type 2 diabetes mellitus and reduce weight. It is a 60 cm long impermeable sleeve-like device that is inserted through your 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 alter natural your level of hunger and fullness.
What will happen to me if I take part?
If you are interested in this study we will invite you for a screening visit. If you decide to participate you will be asked to sign an informed consent form. Your doctor will then perform some tests and procedures to determine whether you are eligible for the study.
If you are eligible for the study you will be randomised to either receive the EndoBarrier device for 12 months and subsequently a diet for a further 12 months after the implant, or you will receive a standard medical therapy and a diet for 24 months. All patients will receive specialist support from a doctor specialising in the treatment of diabetes and a dietitian.
Randomisation means that a group of people are split into two groups at random; one group is given one intervention (the EndoBarrier device) and the other is given a different intervention (standard medical therapy/ control group). We then measure how each group is doing and see if one group has achieved its supposed outcome any better.
Who are we looking for?
- Male or female
- 18-65 years
- T2DM for at least 1 year (HbA1c 7.5-10.0% = 58-86 mmol/mol)
- On oral T2DM medications
- BMI 30-50 kg/m2
- Current use of insulin
- Previous diagnosis with Type 1 DM
- Requirement of NSAIDs or prescription of anticoagulation therapy
- Severe liver or kidney failure
- Severe depression or unstable psychological characteristics
How can I find out more?
1. Call us: 020 331 25745 or 07872850052
2. Email us: firstname.lastname@example.org or email@example.com
3. Write to us: Imperial College NHS Trust, St Mary’s Hospital
First Floor, Mint Wing, Office 3, Praed Street, Paddington, London, W2 1NY
4. Find us through our Website: www.tinyurl.com/endobarrier
5. Find us on Facebook: EndoBarrier TM Gastrointestinal Liner Diabetes Trial / London
6. Find us on Twitter: @Diabetes_trial