Extrait

Background and study aims Type 2 diabetes is a major risk factor for heart disease, kidney failure and other complications. Insulin therapy is often needed in type 2 diabetes to help control your blood sugars to help reduce these complications. However, insulin therapy can lead to weight gain. Therefore, there is a need to develop interventions to help patients reduce or even come off insulin therapy. Research has shown that using low calorie diets can produce significant weight loss. This research study will test if weight loss through a liquid meal replacement low calorie diet can help you lose weight and reduce or even help you come off your insulin and help reduce the complications associated with your diabetes. This study will aim to recruit 90 patients from North West London to assess the impact of a liquid low calorie diet compared with good clinical care on weight loss and insulin requirements within people with type 2 diabetes requiring insulin. Who can participate? Men and women with type 2 diabetes, aged 18-70, who have a Body Mass Index (BMI) over 30 kg/m², are willing and able to give informed consent for participation in the study, and have been on insulin for no more than 10 years. What does the study involve? Patients will be randomly allocated to receive either the low calorie diet or routine care for 6 months. This study will use between 800 calories as a benchmark for the low calorie diet. For the first 12 weeks, the patients will be asked to consume a low calorie diet. After this, the patients in the low calorie diet group will gradually have conventional food re-introduced for the next 12 weeks. Patients in the routine care group will be asked to consume a 600 calorie deficit diet throughout the intervention. After 6 months, all patients will be transferred to the same care and follow a 600 calorie deficit diet and will be followed up for 6 months. What are the possible benefits and risks of participating? There are no direct benefits from taking part in the study. The study will hopefully help to improve the management of patient within type 2 diabetes on insulin. There is a risk of low blood sugar; the research team will help educate the patient to manage their low blood sugars, adjust their insulin with partnership of the GP and therefore reduce the risk. When having blood taken there is a small chance of fainting, bruising, bleeding, swelling or infection where the needle was inserted. The risk will be minimised by having qualified and experienced staff members perform this procedure. Where is the study run from? Imperial College London (UK). When is the study starting and how long is it expected to run for? The study will start in September 2014 and will last for 36 months. Who is funding the study? Cambridge Weight Plan Ltd (UK). Who is the main contact? Professor Gary Frost [email protected]

Critère d'inclusion

• Type 2 Diabetes

Liens

• isrctn
• ictrp