Epicardial Adipose Tissue Thickness in Polycystic Ovary Syndrome (PCOS)

This study has been completed.
Sponsor:
Information provided by:
Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01258946
First received: December 10, 2010
Last updated: June 10, 2011
Last verified: August 2010
  Purpose

The aim of the present study was to search whether epicardial adipose tissue thickness, a predictor of increased cardiovascular risk, increases in PCOS patients or not and, if it does, to analyze the relationship of EATT with insulin resistance, adiponectin and biochemical and anthropometric parameters.


Condition Phase
Epicardial Adipose Tissue Pcos
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relationship Between Epicardial Adipose Tissue Thickness, Insulin Resistance and Plasma Adiponectin Concentrations In Patients With Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • Mean EATT and HOMA-IR levels were significantly higher (p=0.001, p=0.001, respectively) while plasma adiponectin concentrations were significantly lower (p=0.0032) in patients with PCOS than controls. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    june 2009-june 2010

  • HOMA-IR, triglyceride levels, HDL-Cholesterol, LH/FSH ratio were most powerful determinants of EATT in logistic regression modeling (p=0.016, p=0.021, p=0.049, p=0.039, respectively) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    June 2009-June 2010


Secondary Outcome Measures:
  • Level of plasma adiponectin was lower in patients with pcos. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    june 2009- june 2010


Enrollment: 45
Study Start Date: January 2009
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Context: Polycystic ovary syndrome (PCOS) is characterized with chronic oligo/unovulations, hyperandrogenism and insulin resistance. Insulin resistance is mostly attributed to visceral adipose tissue. Epicardial adipose tissue thickness (EATT) is in close relation with atherosclerotic coronary heart disease and its importance in PCOS is not determined yet. Thus, we aimed to clarify EATT in patients with PCOS and compare with healthy matched controls. In addition we searched plasma adiponectin levels to clarify its relationship with EATT in patients with PCOS.

Settings: EATT was determined by echocardiography. Insulin resistance is calculated as HOMA-IR and plasma adiponectin levels were determined with ELISA radioimmunoassay at Gülhane School of Medicine, Ankara, Turkey.

Patients: Patients with PCOS and healthy controls who were similar in body mass index (BMI) and age (p=0.118, p=0.081, respectively) were enrolled in the study after having their written consents.

Results: Mean EATT and HOMA-IR levels were significantly higher (p=0.001, p=0.001, respectively) while plasma adiponectin concentrations were significantly lower (p=0.0032) in patients with PCOS than controls. There was no correlation between plasma adiponectin levels and EATT in subjects (p=0.824). EATT levels were in positive correlation with HOMA-IR, plasma triglyceride concentrations and body mass index (BMI) (p=0.022, p=0.027, p=0.022, respectively). HOMA-IR, triglyceride levels, HDL-Cholesterol, LH/FSH ratio were most powerful determinants of EATT in logistic regression modeling (p=0.016, p=0.021, p=0.049, p=0.039, respectively).

Conclusion: EATT is increased in patients with PCOS in concordance with HOMA-IR level and these findings may reflect the increased risk for atherosclerotic cardiovascular disease in this particular patient group.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

45 patients wit pcos and 45 control cases

Criteria

Inclusion Criteria:

  • pcos patients, all of the women had normal thyroid-stimulating hormone and prolactin levels, and subjects without possible ovarian tumors, congenital adrenal hyperplasia

Exclusion Criteria:

  • BMI greater than 35 kg/m2, any chronic renal or liver disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01258946

Locations
Turkey
Gulhane School of Medicine
Ankara, Turkey, 06010
Sponsors and Collaborators
Gulhane School of Medicine
  More Information

No publications provided

Responsible Party: Dr. Aydogan Aydogdu, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01258946     History of Changes
Other Study ID Numbers: 1491-764-10/1539, epicardial adipose tissue
Study First Received: December 10, 2010
Last Updated: June 10, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Gulhane School of Medicine:
epicardial adipose 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 July 23, 2014