Polycystic Ovary Syndrome and Niacin

• Research type

  Research Study

• Full title

  To determine if cardiovascular risks indices including postprandial hypertriglyceridaemia are modified favourably by nicotinic acid (niacin) in patients with polycystic ovary syndrome (PCOS)

• IRAS ID

  29965

• Contact name

  Stephen L Atkin

• Sponsor organisation

  Research & Development Department, Hull & East Yorkshire Hospitals NHS Trust

• Eudract number

  2009-015729-35

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Polycystic ovary syndrome is a common hormone problem in young women and, as a result of it, they can experience irregular periods, reduced fertility, acne and increased body hair. Frequently, increased weight is a feature. Research suggests that they could have a higher risk of diabetes, high cholesterol and cardiovascular disease such as high blood pressure, angina, heart attack and stroke. The fat from the diet is transported from the stomach and bowel into the blood and then taken up by the liver, muscles and fat tissues to store or use as an energy source. Delayed removal of fat from the circulation resulting rise of fat after a meal has been known to happen in PCOS. High fats after a meal are a strong risk factor for cardiovascular disease. Niacin has been in clinical use to lower bad cholesterol and to increase good cholesterol for many years. It has been proved to be effective in reducing heart attacks in patients with diabetes or with angina. However the effect of niacin on reducing cardiovascular risks and reducing fat level after a meal in PCOS has not been studied and this is why we plan to do this research. It will be carried out at diabetes centre, Hull Royal Infirmary. Patients with PCOS who do not have diabetes will be generally eligible for study. Participants need to attend 6 visits, 2 visits before prescribing study medicine/placebo, 2 visits while on the study medicine/placebo and 2 visits at the end of 12 weeks treatment. Study procedures include blood sampling, an oral glucose tolerance test, a meal test and Endopat, a non invasive test to study the function of the arteries, before and after treatment. Their participation would be 4-6 months but the whole study will take up to 16 months.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/103

• Date of REC Opinion

  19 Nov 2009

• REC opinion

  Further Information Favourable Opinion