Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Polycystic Ovary Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS cohort<br>Women with PCOS as diagnosed by the NIH criteria | |
| Control cohort<br>Women without PCOS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls | 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 | Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of concentrations of androgens in women with PCOS compared with controls | Bloods were taken in the fasted state and circulating concentrations of androgens (DHEAS, testosterone, androstenedione) were assessed | 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 | Bloods were taken in the fasted state and circulating concentrations of lipids assessed | Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion | 
| Assessment of inflammatory profile in women with PCOS compared with controls | Bloods were taken in the fasted state and circulating concetrations of several important markers of inflammation as well as key adipokines were assessed | Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion | 

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