Extrait

Background and study aims Up to 15% of pregnant women develop a temporary type of diabetes during pregnancy called gestational diabetes mellitus (GDM). In GDM, women develop high blood sugar levels as the body is unable to produce enough insulin (a hormone that helps convert sugar into stored energy). GDM is associated with increased risks for mother and baby including increased risk of later life diabetes for the mother and increased risk of childhood obesity for the baby. If a woman overweight or obese or has previously had GDM, then their risk of developing it is higher. Treatments during pregnancy to reduce the risk of GDM to date have been unsuccessful, and so it is important to look at the months before pregnancy as a time to intervene and reduce the chance of developing GDM in a subsequent pregnancy. Optimising mother’s health prior to a pregnancy holds considerable potential to improve mother and baby’s health in pregnancy. This study is looking at one such intervention in women at risk of GDM before pregnancy. The aim of this study is to find out whether this programme, which includes intensive lifestyle changes and treatment with a medication called Liraglutide, is feasible and acceptable to women. Who can participate? Women who are obese (without being diabetic) and/or have previously had GDM. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group take part in the GDM prevention intervention. This involves taking part in an intensive lifestyle change programme involving a healthy diet and physical activity, as well as receiving daily injections of liraglutide (a drug which mimics the action of a protein called GLP-1 which triggers the release of insulin). Those in the second group receive intensive lifestyle advice also. Participants in both groups come to a clinic service in a monthly basis over a 6-month period, where various measurements and blood collection are carried out. What are the possible benefits and risks of participating? Participants may benefit from potentially improved the blood sugar levels and a reduction of the incidence of diabetes in subsequent pregnancies, as well as improved control of blood glucose in participants with type 2 diabetes mellitus and a reduction body weight. Liraglutide is generally tolerated well, however the most frequently reported adverse effects of Liraglutide are gastrointestinal (gut), more than 5% of patients will present with nausea, diarrhoea, vomiting, constipation, abdominal pain, and dyspepsia (indigestion). Serious side effects are rare during Liraglutide treatment. Where is the study run from? National Maternity Hospital (Ireland) When is the study starting and how long is it expected to run for? September 2016 to December 2020 Who is funding the study? University College Dublin (Ireland) Who is the main contact? Professor Fionnuala McAuliffe [email protected]

Critère d'inclusion

• 1. Gestational diabetes 2. Glucose intolerance 3. Obesity

Liens

• isrctn