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

Polycystic Ovary Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118598
• Other study ID #: R0920 PCOS & Niacin
• Secondary ID: ISRCTN37787683
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Hull & East Yorkshire Hospitals NHS Trust	Hull

Sponsors (2)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. Diabet — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in postprandial triglyceride	Postprandial triglyceride will be measured using meal test.	3 months
Secondary	Reduction in high sensitivity C-reactive protein (CRP)		3 months
Secondary	Improvement in peripheral arterial tone (PAT- index)	Peripheral arterial tone (PAT- index) will be measured using ENDO PAT 2000 before and after intervention	3 months

External Links

•   publication link