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

Study Overview
=================
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.

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)

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: tredaptive (nicotinic acid/ laropiprant)
* Drug: placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo arm<br>this group will receive placebo as per protocol | Drug: placebo<br>* placebo tablet one a day for first 4 weeks followed by two a day for 8 weeks<br>|
| Active Comparator: tredaptive<br>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)<br>* tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks<br>* Other names: tredaptive;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in postprandial triglyceride | 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) |  | 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 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS