CV risk in PCOS and NASH

• Research type

  Research Study

• Full title

  Are early and late cardiovascular risk markers in women with Polycystic Ovary Syndrome increased with concomitant Nonalcoholic Steatohepatitis and can this be modified with Exenatide?

• IRAS ID

  15254

• Sponsor organisation

  Hull and East Yorkshire NHS Trust

• Eudract number

  2008-006928-55

• ISRCTN Number

  n/a

• Research summary

  Title Are markers of heart disease in women with Polycystic Ovary Syndrome and Nonalcoholic Steatohepatitis increased compared to each condition alone, and can these markers be improved with Exenatide?Why is this important?Polycystic Ovary Syndrome (PCOS) is a common condition affecting women of reproductive age and these women are more likely to suffer from fatty liver disease, including Nonalcoholic Steatohepatitis (NASH) - an inflamed fatty liver. Women with either of these conditions have an increased risk of heart disease, but the effect of both PCOS and NASH on markers of heart disease is unknown. It is important know this as detection and treatment at an early stage could reduce heart disease.Exenatide is an injection treatment used in diabetes and has been shown to improve some effects of PCOS (improving menstrual cycles and abdominal fat) but the markers of heart disease have not been examined. It is thought that Exenatide could improve NASH but this has not been examined. This study will examine the markers of heart disease and the effect of Exenatide; knowledge learnt from this will hopefully improve the management of each condition.What condition is being studied?PCOS and NASHWho would be eligible?Women aged 16-45 years who have symptoms and signs of PCOS, and women who have NASH.Where will the study take place?Hull Royal InfirmaryHow long will the study last, and what will the participants undergo?The study will last for about 6 months, and initially PCOS and NASH will be confirmed by blood tests, ultrasound scans and a liver biopsy if clinically indicated. Before starting Exenatide blood tests looking for markers of heart disease, EndoPAT examining blood flow in the fingers and Fibroscan looking at NASH will be done. These will be repeated once the participant has completed 4 months of treatment. Further care will be discussed at the final clinic appointment

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/9

• Date of REC Opinion

  9 Mar 2009

• REC opinion

  Further Information Favourable Opinion