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Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome

Information source: Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: tredaptive (nicotinic acid/ laropiprant) (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hull and East Yorkshire Hospitals NHS Trust

Official(s) and/or principal investigator(s):
Stephen L Atkin, FRCP, PhD, Principal Investigator, Affiliation: University of Hull

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Reduction in postprandial triglyceride

Secondary outcome:

Reduction in high sensitivity C-reactive protein (CRP)

Improvement in peripheral arterial tone (PAT- index)

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

Hull & East Yorkshire Hospitals NHS Trust, Hull HU3 2RW, United Kingdom
Additional Information

Starting date: June 2010
Last updated: September 10, 2012

Page last updated: August 23, 2015

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