To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic Ovary Syndrome ( PCOS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Reduction in postprandial triglyceride
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged between 18 - 50 years
- •Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement
排除标准
- •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
研究组 & 干预措施
placebo arm
this group will receive placebo as per protocol
干预措施: placebo (Drug)
tredaptive
tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
干预措施: tredaptive (nicotinic acid/ laropiprant) (Drug)
结局指标
主要结局
Reduction in postprandial triglyceride
时间窗: 3 months
Postprandial triglyceride will be measured using meal test.
次要结局
- Reduction in high sensitivity C-reactive protein (CRP)(3 months)
- Improvement in peripheral arterial tone (PAT- index)(3 months)