Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

— CS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195168
• Other study ID #: DDC-UCD-CS
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: September 3, 2010
• Start date: November 2006
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: The Adelaide and Meath Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Locations

Country	Name	City	State
Ireland	Diabetes Day Centre, The Adelaide and Meath Hosptial	Dublin	Leinster
Ireland	Nutrigenomics Research Group, University College Dublin	Dublin	Leinster

Sponsors (2)

Lead Sponsor	Collaborator
The Adelaide and Meath Hospital	University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No