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

Hull University Teaching Hospitals NHS Trust34 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

tredaptive (nicotinic acid/ laropiprant)DRUG

tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks

placeboDRUG

placebo tablet one a day for first 4 weeks followed by two a day for 8 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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 (1)

Hull & East Yorkshire Hospitals NHS Trust

Hull, United Kingdom

Outcomes

Primary Outcomes

Reduction in postprandial triglyceride

Postprandial triglyceride will be measured using meal test.

Time frame: 3 months

Secondary Outcomes

Reduction in high sensitivity C-reactive protein (CRP)

Time frame: 3 months

Improvement in peripheral arterial tone (PAT- index)

Peripheral arterial tone (PAT- index) will be measured using ENDO PAT 2000 before and after intervention

Time frame: 3 months

Data from ClinicalTrials.gov

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