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

This study has been completed.
Sponsor:
Collaborator:
University College Dublin
Information provided by:
The Adelaide and Meath Hospital
ClinicalTrials.gov Identifier:
NCT01195142
First received: September 2, 2010
Last updated: September 3, 2010
Last verified: July 2008
History of Changes
  Purpose

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.


Condition
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Adipose Tissue Gene Expression Profiles in Women With PCOS Versus Controls Matched for BMI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Adelaide and Meath Hospital:

Primary Outcome Measures:
  • Transcriptomic profiling of subcutaneous adipose tissue of women with PCOS and age and BMI matched controls [ Time Frame: Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion ] [ Designated as safety issue: No ]
    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:
  • Measurement of biomarkers of metabolic health (lipid, inflammatory markers) in plasma of PCOS cases and controls [ Time Frame: Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 10
Study Start Date: December 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
PCOS-CSAT
Women with PCOS
Control-CSAT
Control population consisting of women without PCOS, matched for age and BMI with the PCOS cohort

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195142

Locations
Ireland
Nutrigenomics Group, University College Dublin
Dublin, Leinster, Ireland, Dublin 4
Diabetes Day Centre, The Adelaide and Meath Hosptial
Dublin, Ireland, 24
Sponsors and Collaborators
The Adelaide and Meath Hospital
University College Dublin
Investigators
Principal Investigator: James Gibney, Dr The Adelaide and Meath Hospital
Principal Investigator: Helen M Roche, Dr University College Dublin
  More Information

No publications provided

Responsible Party: Dr James Gibney, AMNCH
ClinicalTrials.gov Identifier: NCT01195142     History of Changes
Other Study ID Numbers: DDC-UCD-ATCS
Study First Received: September 2, 2010
Last Updated: September 3, 2010
Health Authority: Ireland: Research Ethics Committee

Keywords provided by The Adelaide and Meath Hospital:
PCOS

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013