Extrait

Background and study aims Polycystic ovary syndrome (PCOS) is commonly associated with obesity, high levels of free fatty acids and insulin resistance (a condition in which the body produces insulin, but the cells in the body become resistant to it and are unable to use it effectively). Therefore, women with PCOS are at risk of diabetes and heart disease. Over 50 years ago, it was proposed that excessive fat (free fatty acids) interferes with skeletal muscle insulin resistance. Women with PCOS are found to have an insulin signalling defect. This study aimed to examine the effect of lipid infusion (a mixture of soya oil, glycerol, purified egg phospholipids and phosphate supplement given through a vein) on insulin resistance in PCOS compared to controls. Secondly it aimed to investigate the effect of moderate intensity exercise, which promotes fat utilization, on basal and lipid-induced insulin resistance in PCOS. Then we examine the effect of exercise on cardiovascular risk in women with PCOS and healthy volunteers. Who can participate? We recruit healthy women and women with PCOS aged 19-40 years, both lean participants with body mass index (BMI) 18-25 kg/m2 and obese participants with BMI 26-40 kg/m2. What does the study involve? Participants will be randomly allocated to two day procedures of either saline or intralipid infusion for 5 hours. All participants receive an 8-week program of supervised moderate intensity exercise. What are the possible benefits and risks of participating? Participants would improve their physical fitness and insulin resistance and subsequent cardiovascular risk at the end of the exercise program. The exercise intervention should not harm the participants apart from possible aches and pain in muscles at the beginning. During the insulin sensitivity measurement, there is a slight chance of lowering of blood glucose level (hypoglycaemia) that will be closely monitored and corrected appropriately. Lipid infusion contains soya oil, glycerol, purified egg phospholipids and phosphate. It is licensed to use as nutritional supplement given through the vein to have a quick effect. Possible adverse effects are occasional febrile (fits) episodes and rarely (i.e. less than 1 in 1000 patients reported) severe allergic reactions. Appropriate safety measures are in place in the department and the whole test will be supervised and monitored by the experienced study doctor and staff. Inserting the cannulas (tubes) and taking blood samples may well cause discomfort and risks of inflammation/infection/bruising at the needle site. The risk will be minimised as the cannulation will be performed by the experienced study doctor in accordance with the local guidelines. Where is the study run from? This study is conducted at a single unit, the research diabetes centre, Hull Royal Infirmary. When is the study starting and how long is it expected to run for? The study started in October 2010 and will run until October 2014. Who is funding the study? The funding is provided by diabetes endowment fund and Hull York Medical School. Who is the main contact? Prof Stephen Atkin [email protected]

Critère d'inclusion

• Polycystic ovary syndrome

Liens

• ictrp
• isrctn