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

July 11, 2019 updated by: Hull University Teaching Hospitals NHS Trust

To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo arm
this group will receive placebo as per protocol
Drug: placebo
placebo tablet one a day for first 4 weeks followed by two a day for 8 weeks
ACTIVE_COMPARATOR: tredaptive
tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
Drug: tredaptive (nicotinic acid/ laropiprant)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in postprandial triglyceride
Time Frame: 3 months
Postprandial triglyceride will be measured using meal test.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in high sensitivity C-reactive protein (CRP)
Time Frame: 3 months
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Stephen L Atkin, FRCP, PhD, University of Hull

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (ESTIMATE)

May 6, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R0920 PCOS & Niacin
  • ISRCTN37787683 (REGISTRY: ISRCTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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