Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
tredaptive (nicotinic acid/ laropiprant)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS
Eligibility 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
Sites / Locations
- Hull & East Yorkshire Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo arm
tredaptive
Arm Description
this group will receive placebo as per protocol
tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
Outcomes
Primary Outcome Measures
Reduction in postprandial triglyceride
Postprandial triglyceride will be measured using meal test.
Secondary Outcome Measures
Reduction in high sensitivity C-reactive protein (CRP)
Improvement in peripheral arterial tone (PAT- index)
Peripheral arterial tone (PAT- index) will be measured using ENDO PAT 2000 before and after intervention
Full Information
NCT ID
NCT01118598
First Posted
May 4, 2010
Last Updated
July 11, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01118598
Brief Title
Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo arm
Arm Type
Placebo Comparator
Arm Description
this group will receive placebo as per protocol
Arm Title
tredaptive
Arm Type
Active Comparator
Arm Description
tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
Intervention Type
Drug
Intervention Name(s)
tredaptive (nicotinic acid/ laropiprant)
Other Intervention Name(s)
tredaptive
Intervention Description
tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet one a day for first 4 weeks followed by two a day for 8 weeks
Primary Outcome Measure Information:
Title
Reduction in postprandial triglyceride
Description
Postprandial triglyceride will be measured using meal test.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Reduction in high sensitivity C-reactive protein (CRP)
Time Frame
3 months
Title
Improvement in peripheral arterial tone (PAT- index)
Description
Peripheral arterial tone (PAT- index) will be measured using ENDO PAT 2000 before and after intervention
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen L Atkin, FRCP, PhD
Organizational Affiliation
University of Hull
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hull & East Yorkshire Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2RW
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24401089
Citation
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. Diabetes Obes Metab. 2014 Jun;16(6):545-52. doi: 10.1111/dom.12255. Epub 2014 Feb 9.
Results Reference
result
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Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome
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