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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Adipose Tissue Gene Expression Profiles in Women With PCOS Versus Controls Matched for BMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195142
• Other study ID #: DDC-UCD-ATCS
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: September 3, 2010
• Start date: December 2007
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• 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
Ireland	Nutrigenomics 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	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	No
Secondary	Measurement of biomarkers of metabolic health (lipid, inflammatory markers) in plasma of PCOS cases and controls	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.	Recruitment ran from Dec 2007-July 2008. Subjects attended the study location fasting on one occasion	No