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Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome

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ClinicalTrials.gov Identifier: NCT01310569
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : March 8, 2011
Sponsor:
Information provided by:
Gulhane School of Medicine

Study Description
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Brief Summary:
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 or disease
Polycystic Ovary Syndrome

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.
Study Design
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Study Type : Observational
Actual Enrollment : 52 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Relationship of Subcutaneous Adipose Tissue with HOMA-IR and Plasma Adiponectin Levels in Cases with Polycystic Ovarian Syndrome [ Time Frame: 2 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes 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
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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): NCT01310569


Locations
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Turkey
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, Turkey, 06100
Sponsors and Collaborators
Gulhane School of Medicine
Investigators
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Study Director: Aydogan Aydogdu, MD Gulhane School of Medicine
More Information
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Responsible Party: Aydogan Aydogdu, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT01310569    
Other Study ID Numbers: 27.04.2010/1491-764-10
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: August 2010
Keywords provided by Gulhane School of Medicine:
PCOS, Skinfold thickness, HOMA-IR
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases