Adipose Tissue Gene Expression Profiles in Women With Polycystic Ovary Syndrome (PCOS) Versus Controls

Completed

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT01195142
• Lead Sponsor: The Adelaide and Meath Hospital

Brief Summary

Adipose tissue is a central organ in mediating metabolic health. There is some evidence that women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which may negatively affect their metabolic health. The aim of this study was to assess transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with a control population matched on the basis of age and body mass index (BMI). A secondary aim was to then relate these gene expression profiles to the biochemical environment.

Detailed Description

Adipose tissue is a central organ in mediating metabolic health. There is some evidence that women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which may negatively affect their metabolic health. The aim of this study was to assess transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with a control population matched on the basis of age and body mass index (BMI). A secondary aim was to then relate these gene expression profiles to the biochemical environment.

Study Timeline

• Study Start: 2007-12
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-03
• Last Update Submitted: 2010-09-03
• Study First Posted: 2010-09-06
• Last Update Posted: 2010-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transcriptomic profiling of subcutaneous adipose tissue of women with PCOS and age and BMI matched controls	Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion	Gene expression profiles from women with PCOS and controls matched for age and BMI were determined by microarray analysis of whole subcutaneous adipose tissue samples. Single gene changes as well as pathway analyses will be used to determine differently expressed genes and pathways between the PCOS cohort and controls.

Secondary Outcome Measures

Name	Time	Method
Measurement of biomarkers of metabolic health (lipid, inflammatory markers) in plasma of PCOS cases and controls	Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion	Biomarkers of metabolic health were assessed in plasma of women with PCOS and age and BMI matched controls. Lipid profile, hormonal profile, various key inflammatory markers and adipokines will be measured. Glucose and insulin concentrations will be assessed also. All parameters will be assessed following a 12 hour over night fast at the study location.

Trial Locations

Locations (2)

Diabetes Day Centre, The Adelaide and Meath Hosptial; 🇮🇪 Dublin, Ireland

Nutrigenomics Group, University College Dublin; 🇮🇪 Dublin, Leinster, Ireland