Effect of Nicotinic Acid on Cardiovascular Risks Indices in Polycystic Ovary Syndrome
To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)
2 other identifiers
interventional
34
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2010
CompletedFirst Posted
Study publicly available on registry
May 6, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJuly 15, 2019
July 1, 2019
1.9 years
May 4, 2010
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in postprandial triglyceride
Postprandial triglyceride will be measured using meal test.
3 months
Secondary Outcomes (2)
Reduction in high sensitivity C-reactive protein (CRP)
3 months
Improvement in peripheral arterial tone (PAT- index)
3 months
Study Arms (2)
placebo arm
PLACEBO COMPARATORthis group will receive placebo as per protocol
tredaptive
ACTIVE COMPARATORtablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
Interventions
tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
Eligibility Criteria
You may qualify if:
- Females aged between 18 - 50 years
- Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hull & East Yorkshire Hospitals NHS Trust
Hull, HU3 2RW, United Kingdom
Related 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. Diabetes Obes Metab. 2014 Jun;16(6):545-52. doi: 10.1111/dom.12255. Epub 2014 Feb 9.
PMID: 24401089RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen L Atkin, FRCP, PhD
University of Hull
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2010
First Posted
May 6, 2010
Study Start
June 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
July 15, 2019
Record last verified: 2019-07