Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS) (CS)

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

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 Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland, Dublin 24
      • Diabetes Day Centre, The Adelaide and Meath Hosptial
    • Dublin, Leinster, Ireland, Dublin 4
      • Nutrigenomics Research Group, University College Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with PCOS and a control population of women matched for age and body mass index (BMI) and insulin resistance

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control cohort; Women without PCOS
PCOS cohort; Women with PCOS as diagnosed by the NIH criteria

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Adelaide and Meath Hospital
• Collaborators: University College Dublin

Publications and helpful links

General Publications

• Gidwani S, Phelan N, McGill J, McGowan A, O'Connor A, Young IS, Gibney J, McEneny J. Polycystic ovary syndrome influences the level of serum amyloid A and activity of phospholipid transfer protein in HDL(2) and HDL(3). Hum Reprod. 2014 Jul;29(7):1518-25. doi: 10.1093/humrep/deu115. Epub 2014 May 19.
• Phelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 3, 2010
• First Posted (Estimate): September 6, 2010

Study Record Updates

• Last Update Posted (Estimate): September 6, 2010
• Last Update Submitted That Met QC Criteria: September 3, 2010
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: PCOS
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: DDC-UCD-CS