Assessment of Cardiovascular Risk in PCOS-a Cross Sectional Study of Women With PCOS Compared With Controls Matched for Age, Body Mass Index and, or Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls
研究概览
简要总结
Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more insulin resistant than women without the condition and may be at greater risk of developing cardiovascular disease. It is not know whether it is the overweight and insulin resistant component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The aim of this study was to examine cardiovascular risk markers in women with PCOS versus a control population matched for body mass index (BMI), and or, insulin resistance
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
- •Were between the ages of 18 and 40
排除标准
- •Were under 18 years or greater than 40 years old,
- •Were non-Caucasian
- •Were pregnant, lactating or trying to conceive
- •Had a body mass index (BMI) <18kg/m2 or >50kg/m2
- •Had a recent illness or any chronic illness likely to influence results
- •Were taking hormonal contraception
结局指标
主要结局
Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls
时间窗: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion
Subjects underwent a standard 75g oral glucose tolerance test (OGTT) and blood were taken fasting and at 2 hours. Surrogate markers of insulin resistance (HOMA) and insulin sensitivity (Avignon index of Insulin Sensitivity; QUICKI) were calculated
次要结局
- Assessment of inflammatory profile in women with PCOS compared with controls(Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion)
- Assessment of concentrations of androgens in women with PCOS compared with controls(Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion)
- Assessment of lipid profile in women with PCOS compared with age matched controls(Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion)