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Completed

NCT Number: NCT01195168

Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)

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

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Assessment of Insulin resistance in women with PCOS compared with BMI and age matched controls

    Time frame: 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 outcomes

  1. Assessment of concentrations of androgens in women with PCOS compared with controls

    Time frame: 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

  2. Assessment of lipid profile in women with PCOS compared with age matched controls

    Time frame: 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

  3. Assessment of inflammatory profile in women with PCOS compared with controls

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Adelaide and Meath Hospital

Other

Collaborators

  • University College Dublin

Registry information

Official study title

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

Acronym: CS

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 6, 2010
Registry last updated
Sep 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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