Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)

Completed

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT01195168
• Lead Sponsor: The Adelaide and Meath Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-03
• Last Update Submitted: 2010-09-03
• Study First Posted: 2010-09-06
• Last Update Posted: 2010-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls	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

Secondary Outcome Measures

Name	Time	Method
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	Bloods were taken in the fasted state and circulating concetrations of several important markers of inflammation as well as key adipokines were assessed
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	Bloods were taken in the fasted state and circulating concentrations of androgens (DHEAS, testosterone, androstenedione) were assessed
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	Bloods were taken in the fasted state and circulating concentrations of lipids assessed

Trial Locations

Locations (2)

Diabetes Day Centre, The Adelaide and Meath Hosptial; 🇮🇪 Dublin, Leinster, Ireland

Nutrigenomics Research Group, University College Dublin; 🇮🇪 Dublin, Leinster, Ireland