Extrait

Background and study aims The management of type 2 diabetes is challenging. Life-long medical therapy and changes in lifestyle (diet and exercise) are poorly accepted by most patients. Therefore, new options for diabetes treatment are required. Patients with type 2 diabetes who undergo obesity surgery (e.g. gastric bypass) see improvements in their blood sugar levels within days (and before they lose weight). However, obesity surgery is rarely used as a treatment for type 2 diabetes because of its expense and risks. This study is designed to see whether a new device called the EndoBarrier, a 60 cm long impermeable sleeve-like device inserted into the intestine, helps patients manage their blood sugar levels, lose weight and reduce other conditions related to obesity compared to standard medical therapy. The EndoBarrier device does not require surgery, yet the device appears to provide similar benefits to patients in terms of improving their blood glucose control. The EndoBarrier device also appears to help people to lose weight and is therefore useful in the treatment of obesity and other health problems related to being overweight e.g. high blood pressure. The purpose of this study is to see how effective the EndoBarrier is compared to standard medical care for diabetes treatment and weight loss and also to better understand the ways in which the EndoBarrier specifically works. Who can participate? Patients aged 18-65 who have had type 2 diabetes for at least 1 year. What does the study involve? 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 randomly allocated to either receive the EndoBarrier device for 12 months and subsequently a diet for a further 12 months, or you will receive 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. On some of the study visits, we will also ask you to participate in specific tests which will help us to assess your metabolism, brain activity, insulin sensitivity and food preference. Participation in these tests is entirely optional. More information about these tests can be found in the patient information sheet. What are the possible benefits and risks of participating? The direct benefit of taking part in this study will be a possible improvement in your blood glucose and HbA1c, blood pressure, weight loss and reduction in long-term health risks, particularly cardiovascular diseases. The risks associated with the EndoBarrier procedure include the same risks observed with other upper gastrointestinal endoscopic procedures. The EndoBarrier device has been safely used in several clinical trials and in more than 300 subjects with both obesity and type 2 diabetes. Where is the study run from? Study visits will either be performed at Imperial College London (St. Mary’s Hospital or Hammersmith Hospital in London) or University Hospital Southampton (Southampton General Hospital). When is the study starting and how long is it expected to run for? The study will run from November 2014 to November 2018. Who is funding the study? NIHR Efficacy and Mechanisms Evaluation (UK). Who is the main contact? Dr Christina Prechtl [email protected]

Critère d'inclusion

• Topic: Diabetes; Subtopic: Type 2; Disease: Device studies, Diabetic Control, Hypoglycemia, Metabolic, Nutrition, Obesity

Liens

• isrctn
• ictrp