Clinical trial NCT01118598: Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome
Official title: To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-05-06
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its lipid lowering as well as via pleiotropic effects in patients with polycystic ovary syndrome (PCOS).

Detailed description: 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 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 risks of heart disease in patients with diabetes. 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.

Eligibility criteria: Inclusion Criteria:

* Females aged between 18 - 50 years
* Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement

Exclusion Criteria:

* Pregnancy/trying to conceive/breast feeding
* History of cardiovascular, renal, hepatic and active thyroid disease
* History of gout
* History of alcohol abuse
* History of diabetes
* History of allergy to nicotinic acid/laropiprant or food
* History of bleeding disorders/active peptic ulcers
* Patient on antihypertensive medications
* Patient on anticoagulants
* Patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents
* History of smoking more than 15 pack year
* Unwilling for GP to be informed

Primary outcomes:
measure: Reduction in postprandial triglyceride
timeFrame: 3 months
Secondary outcomes:
measure: Reduction in high sensitivity C-reactive protein (CRP)
timeFrame: 3 months
measure: Improvement in peripheral arterial tone (PAT- index)
timeFrame: 3 months
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull & East Yorkshire Hospitals NHS Trust
Study officials:
affiliation: University of Hull
name: Stephen L Atkin, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aye MM, Kilpatrick ES, Afolabi P, Wootton SA, Rigby AS, Coady AM, Sandeman DD, Atkin SL. Postprandial effects of long-term niacin/laropiprant use on glucose and lipid metabolism and on cardiovascular risk in patients with polycystic ovary syndrome. Diabetes Obes Metab. 2014 Jun;16(6):545-52. doi: 10.1111/dom.12255. Epub 2014 Feb 9.