Extract

Background and study aims: Polycystic ovary syndrome (PCOS) is a common condition in women of reproductive age. PCOS is associated with cardiovascular risk through increased insulin resistance. This in turn may lead to increased risk of non-alcoholic fatty liver disease (NAFLD). Both conditions are made worse by obesity. Liraglutide has been shown to reduce weight, but it is unknown if liraglutide improves cardiovascular risk factors in women with PCOS with or without NALFD. Who can participate? Two groups of women: 20 with PCOS; 20 age and weight matched normal control subjects. What does the study involve? Participants are treated with liraglutide 1.8mg once a day for 6 months followed by metformin 500mg three times a day for 3 months. Study participants will be seen every 3 months. At each visit blood will be taken to measure for insulin resistance, and for clotting and inflammations markers. Artery wall thickness will be measured at baseline and after 6 months treatment with liraglutide. What are the possible benefits and risks of participating? There will be no immediate direct benefit to those taking part but the study will improve our understanding of PCOS and the treatment of people with PCOS and fatty liver disease. Most common side effects with metformin and liraglutide use are nausea and diarrhoea. These side effects usually disappear after a few days. There might be some discomfort in blood testing and endothelial function measurement. Where is the study run from? Diabetes Research Centre at Hull Royal Infirmary (UK). When is the study starting and how long is it expected to run for? May 2010 to December 2012. Who is funding the study? Diabetes Research fund, University of Hull (UK). Who is the main contact? Professor Stephen L Atkin [email protected]

Inclusion criteria

• Polycystic ovary syndrome

Links

• ictrp
• isrctn