Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- carotid intima media thickness
研究概览
简要总结
The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of reproductive age. PCOS is associated with various cardiovascular risk factors such as obesity, glucose intolerance, dyslipidemia hypertension and the metabolic syndrome. Whether these increased cardiovascular risk factors result in the development of actual cardiovascular disease in later life remains to be established.
Women with premature ovarian insufficiency (POI), experience menopause prior to the age of 40 years. Women with POI may exhibit dyslipidemia. A young age at menopause has been previously associated with increased cardiovascular morbidity and mortality.
详细描述
Cardiovascular risk profile will be assessed in women with PCOS and POI > 45 years of age, consisting of:
fasting serum and urine analyses blood pressure, length, weight, waist circumference, hip circumference ECG carotid intima media thickness cardiac ultrasound
spare serum, plasma and urine will be stored in -80 degrees celsius biobank.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age above 45 years
排除标准
- 未提供
结局指标
主要结局
carotid intima media thickness
时间窗: 10 years post diagnosis
ultrasound measurement of thickness of carotid wall (mean IMT), presence of atherosclerotic plaques (yes/no, location)
次要结局
- insulin and glucose levels(10 years post diagnosis)
- dyslipidemia(10 years post diagnosis)
- electrocardiogram (ECG)(10 years post diagnosis)
- C-reactive protein(10 years post diagnosis)
- homocysteine(10 years post diagnosis)
- uric acid(10 years post diagnosis)
- androgen levels(10 years post diagnosis)
- cardiac ultrasound (hypertrophy)(10 years post diagnosis)