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Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01195168
Acronym
CS
Enrollment
201
Registered
2010-09-06
Start date
2006-11-30
Completion date
2008-07-31
Last updated
2010-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

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

Interventions

None listed

Sponsors

University College Dublin
CollaboratorOTHER
The Adelaide and Meath Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controlsRecruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasionSubjects 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

MeasureTime frameDescription
Assessment of lipid profile in women with PCOS compared with age matched controlsRecruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasionBloods were taken in the fasted state and circulating concentrations of lipids assessed
Assessment of concentrations of androgens in women with PCOS compared with controlsRecruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasionBloods were taken in the fasted state and circulating concentrations of androgens (DHEAS, testosterone, androstenedione) were assessed
Assessment of inflammatory profile in women with PCOS compared with controlsRecruitment ran from Nov 2006-July 2008; Each subject attended the study location fasting on one occasionBloods were taken in the fasted state and circulating concetrations of several important markers of inflammation as well as key adipokines were assessed

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026