Extrait

Background and study aims Obesity is the main cause of the world wide epidemic of diabetes. Weight loss, or bariatric, surgery produces major and sustained weight loss and is being increasingly used to treat obese diabetic patients. There was initial optimism that these procedures might cure all diabetes. However, the gold-standard operation, standard gastric bypass, effectively cures diabetes in only 4 out of 10 patients. To design a safer and more successful procedure we need to understand how bariatric surgery works to improve diabetes. Hormones from the gut are released when we eat food. They control how the body uses the food it absorbs. For example they release the sugar lowering hormone insulin, and also greatly reduce appetite, which is why one feels less hungry after eating a meal. We have discovered that the good effects of bariatric surgery, and in particular the gastric bypass, are mainly due to increased release of gut hormones, reducing patients appetite and improving the release of insulin. In this project we will be testing a new procedure called the long-limb gastric bypass. It is designed particularly to be better at helping the diabetes in overweight patients, while being as safe as the currently available standard gastric bypass. We now want to show that this new procedure works better than the standard gastric bypass by causing an even bigger increase in the release of gut hormones and therefore insulin. Who can participate? Obese adults (aged 18-70) with type 2 diabetes. What does the study involve? Participants are randomly assigned into one of two groups. Those in group 1 have a standard-limb gastric bypass. Those in group 2 have a long-limb gastric bypass. Using a newly developed technique (mass spectroscopy) we then measure the differences in gut hormone secretion between the new long-limb and the standard gastric bypass. We also use a well-tested insulin sensitivity procedure (glucose clamp), both to confirm and to investigate how and why each participants diabetes has improved after the surgery. What are the possible benefits and risks of participating? The measurements we will be making are non-invasive and safe. The only discomfort comes from inserting a cannula to take blood samples. Where is the study run from? Imperial College London, Hammersmith Hospital (lead centre) and King’s College London (UK) When is the study starting and how long is it expected to run for? August 2015 to February 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Dr Alex Miras

Critère d'inclusion

• Topic: Diabetes; Subtopic: Type 2; Disease: Diabetic Control, Obesity

Liens

• isrctn
• ictrp