ClinicalTrials.gov
ClinicalTrials.gov Menu

Epicardial Adipose Tissue Thickness in Polycystic Ovary Syndrome (PCOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01258946
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : June 13, 2011
Sponsor:
Information provided by:
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.

Condition or disease
Epicardial Adipose Tissue Pcos

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 Type : Observational
Actual Enrollment : 45 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 ]
    june 2009-june 2010

  2. 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 ]
    June 2009-June 2010


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258946


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

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 ( Other Identifier: Gulhane SM )
First Posted: December 13, 2010    Key Record Dates
Last Update Posted: June 13, 2011
Last Verified: August 2010

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