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Completed

NCT Number: NCT01118598

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

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).

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hull & East Yorkshire Hospitals NHS Trust

Hull, HU3 2RW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: tredaptive

Placebo

Drug

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

Primary outcomes

  1. Reduction in postprandial triglyceride

    Time frame: 3 months

    Postprandial triglyceride will be measured using meal test.

Secondary outcomes

  1. Reduction in high sensitivity C-reactive protein (CRP)

    Time frame: 3 months

  2. Improvement in peripheral arterial tone (PAT- index)

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 6, 2010
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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