Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)

N/ACompletedNCT01195168

The Adelaide and Meath Hospital201 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

201

Conditions

Polycystic Ovary Syndrome

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Diabetes Day Centre, The Adelaide and Meath Hosptial

Dublin, Leinster, Ireland

Nutrigenomics Research Group, University College Dublin

Dublin, Leinster, Ireland

Outcomes

Primary Outcomes

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

Time frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Recruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasion

Data from ClinicalTrials.gov

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