Extrait

Background and study aims Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Once of the main reasons why people develop T2DM is because they are overweight or obese. Weight loss surgery, also called bariatric surgery, is a drastic measure used to help people who are dangerously overweight. There are a number of different types of bariatric surgery; however they all work by limiting the amount a person can eat or reducing the number of calories that are absorbed from food. In some patients, bariatric surgery can cause up to 30% weight loss and substantially improve blood glucose control however this is not always the case. Studies have shown that in patients where the procedures are successful, high amounts of a hormone called glucagon like peptide­1 or GLP­1 are produced. This hormone is responsible for causing insulin to be released, which reduces blood sugar. Liraglutide is a drug which has been developed to mimic the action of GLP-1. In the past, it has been given to overweight diabetics who aren’t suitable for bariatric surgery, and has been found to lower blood glucose and weight. The aim of this study is to look at the effects of receiving liraglutide injections on blood glucose and weight in diabetic adults who have not responded well to bariatric surgery. Who can participate? Adults with T2DM who have had a bariatric surgery 12 months ago. What does the study involve? For the first two weeks of the study, all participants are taught how to use the injector pen device and asked to inject themselves with a dummy (placebo) every day. At the end of the two weeks, the devices are measured in order to find out how well each participant stuck to the regime. Participants are then randomly allocated to one of two groups. Participants in the first group are given pens containing liraglutide to use every day. For one week, a dose of 0.6mg/day is taken, then 1.2mg/day for the next week and then 1.8mg/day for the following week. After this, participants are given the opportunity to adjust the dose if they are experiencing a lot of side effects. Participants in the second group are given pens containing a dummy (placebo) to use every day at the same doses as the first group. At the start of the study and then again after 26 weeks, participants in both groups attend follow up appointments so that their weight and blood sugar levels (in a blood test) can be measured. What are the possible benefits and risks of participating? Participants in both groups will benefit from being under the care of a specialist team which they would not normally have access to. The patients taking the liraglutide may also benefit from improvements to their diabetes management and weight loss. There is a risk of pain and discomfort from the injections, as well as when blood is taken to test blood sugar levels. There is also a risk of side effects from the liraglutide, however these will be closely monitored. Where is the study run from? Imperial College London (UK) When is the study starting and how long is it expected to run for? April 2015 to October 2017 Who is funding the study? J P Moulton Charitable Foundation (UK) Who is the main contact? Dr Alex Miras

Critère d'inclusion

• Topic: Diabetes, Metabolic and endocrine disorders; Subtopic: Type 2, Metabolic and Endocrine (all Subtopics); Disease: Diabetic Control, Metabolic & Endocrine (not diabetes)

Liens

• ictrp
• isrctn