Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01310569
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2011-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-07', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-07', 'lastUpdatePostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship of Subcutaneous Adipose Tissue with HOMA-IR and Plasma Adiponectin Levels in Cases with Polycystic Ovarian Syndrome', 'timeFrame': '2 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS, Skinfold thickness, HOMA-IR'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with PCOS witout any other metabolik diseases', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All of the women with PCOS had normal thyroid-stimulating hormone and prolactin (PRL) levels.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT01310569', 'briefTitle': 'Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'officialTitle': 'Relationship of Subcutaneous Adipose Tissue With HOMA-IR and Plasma Adiponectin Levels in Cases With Polycystic Ovarian Syndrome', 'orgStudyIdInfo': {'id': '27.04.2010/1491-764-10'}}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane School of Medicine Department of Endocrinology and Metabolism', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Aydogan Aydogdu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gulhane School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Aydogan Aydogdu', 'oldOrganization': 'Gulhane School of Medicine'}}}}