A Phase 4 interventional study of tredaptive (nicotinic acid/ laropiprant) and placebo in Polycystic Ovary Syndrome, sponsored by Hull University Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-07-15.
Sponsored by Hull University Teaching Hospitals NHS Trust · Phase 4, Interventional, and Treatment
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).
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.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's enrollment of 34 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Hull University Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
this group will receive placebo as per protocol
Drug: placebo
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)
Reduction in postprandial triglyceride
Postprandial triglyceride will be measured using meal test.
Time frame: 3 months
Reduction in high sensitivity C-reactive protein (CRP)
Time frame: 3 months
Improvement in peripheral arterial tone (PAT- index)
Peripheral arterial tone (PAT- index) will be measured using ENDO PAT 2000 before and after intervention
Time frame: 3 months
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Niacin · MK-0524
Hull University Teaching Hospitals NHS Trust