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

NCT01195142 | Completed

• 1 other identifier: DDC-UCD-ATCS
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

Outcome Measures

Primary Outcomes (1)

• Transcriptomic profiling of subcutaneous adipose tissue of women with PCOS and age and BMI matched controls

  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.

  Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion

Secondary Outcomes (1)

• 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

Study Arms (2)

PCOS-CSAT

Women with PCOS

Control-CSAT

Control population consisting of women without PCOS, matched for age and BMI with the PCOS cohort

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Adelaide and Meath Hospital: lead
• University College Dublin: collaborator

Study Sites (2)

Diabetes Day Centre, The Adelaide and Meath Hosptial

Dublin, Dublin, 24, Ireland

Location

Nutrigenomics Group, University College Dublin

Dublin, Leinster, Dublin 4, Ireland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• James Gibney, Dr

  The Adelaide and Meath Hospital

  PRINCIPAL INVESTIGATOR

• Helen M Roche, Dr

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 6, 2010
• Study Start: December 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 6, 2010

Record last verified: 2008-07

Locations

IE (2)