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Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome

This study has been completed.
Sponsor:
Information provided by:
Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01310569
First received: March 7, 2011
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

This study aimed to search whether whole body and subcutaneous adipose tissues increase in PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.


Condition
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Relationship of Subcutaneous Adipose Tissue With HOMA-IR and Plasma Adiponectin Levels in Cases With Polycystic Ovarian Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • Relationship of Subcutaneous Adipose Tissue with HOMA-IR and Plasma Adiponectin Levels in Cases with Polycystic Ovarian Syndrome [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    PCOS patients (the experimental group) had higher mean SFT values in all parts, mid-upper arm circumference values, whole body and trunk fat free mass amounts (FFM) and HOMA-IR values, while a lower adiponectin level.


Enrollment: 52
Study Start Date: January 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Fifty-two patients with PCOS and fifty-tree healthy controls who were matched for body mass index (BMI) and age (p=0.430, p=0.112, respectively) were enrolled in the study. Biceps, triceps, subscapular and suprailiac skinfold thicknesses (SFT) of all cases were measured via caliper device; mid-upper arm circumference (MUAC) via a tape; and body fat distributions via a bioelectrical impedance device. Insulin resistance was calculated via HOMA-IR while ELISA was used to measure plasma adiponectin.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with PCOS witout any other metabolik diseases

Criteria

Inclusion Criteria:

  • All of the women with PCOS had normal thyroid-stimulating hormone and prolactin (PRL) levels.

Exclusion Criteria:

  • Subjects with possible ovarian tumors, congenital adrenal hyperplasia, BMI greater than 35 kg/m2, any chronic renal or liver disease, were excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310569

Locations
Turkey
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, Turkey, 06100
Sponsors and Collaborators
Gulhane School of Medicine
Investigators
Study Director: Aydogan Aydogdu, MD Gulhane School of Medicine
  More Information

No publications provided

Responsible Party: Aydogan Aydogdu, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01310569     History of Changes
Other Study ID Numbers: 27.04.2010/1491-764-10
Study First Received: March 7, 2011
Last Updated: March 7, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Gulhane School of Medicine:
PCOS, Skinfold thickness, HOMA-IR

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