Epicardial Adipose Tissue Thickness in Polycystic Ovary Syndrome (PCOS)

Completed

• Conditions: Epicardial Adipose Tissue Pcos

• Registration Number: NCT01258946
• Lead Sponsor: Gulhane School of Medicine

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-05
• Status Verified: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-13
• Last Update Submitted: 2011-06-10
• Last Update Posted: 2011-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1 year	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)	1 year	June 2009-June 2010

Secondary Outcome Measures

Name	Time	Method
Level of plasma adiponectin was lower in patients with pcos.	1 year	june 2009- june 2010

Trial Locations

Locations (1)

Gulhane School of Medicine; 🇹🇷 Ankara, Turkey