Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-28 @ 9:22 AM
Study NCT ID:
NCT01463969
Status:
COMPLETED
Last Update Posted:
2011-11-02
First Post:
2011-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome (PCOS)
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-01', 'studyFirstSubmitDate': '2011-10-23', 'studyFirstSubmitQcDate': '2011-11-01', 'lastUpdatePostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of of pentraxin3 in cases with Polycystic Ovarian Syndrome', 'timeFrame': '1 year', 'description': 'Mean PTX3 was significantly higher in patients with PCOS. This means that there is increased level of inflamation in patients with PCOS.'}], 'secondaryOutcomes': [{'measure': 'Relationship of PTX3 with insuline resistance in patients with PCOS.', 'timeFrame': '1 year', 'description': 'PTX3 was positively correlated with HOMA-IR. This means that inflamation may cause insuline resistance in patients with PCOS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS and PTX3 levels'], 'conditions': ['PCOS']}, 'descriptionModule': {'briefSummary': 'In the present study, serum pentraxin 3 level and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3 level is increased in patients with PCOS and it is positively correlated with HOMA-IR.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '40 PCOS patients and 40 healty controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Absence of significant abnormalities on physical examination except hirsutism\n* No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy\n* Normal thyroid function and prolactin level\n* Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease\n\nExclusion Criteria:\n\n* Pregnant\n* Possible ovarian tumors,\n* Congenital adrenal hyperplasia or\n* BMI greater than 35 kg/m2'}, 'identificationModule': {'nctId': 'NCT01463969', 'briefTitle': 'High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'officialTitle': 'High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': '23.10.2011'}, 'secondaryIdInfos': [{'id': '24.05.2011', 'type': 'REGISTRY', 'domain': 'pcos and PTX3'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCOS patients'}, {'label': 'Control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06018', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane School of Medicine Dep. of Endocrine and Metabolism', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06018', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane School of Medicine Dep. of Endocrinology and Metabolism', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06018', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane School of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Aydogan Aydogdu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gulhane School of Medicine Dep. of Endocrinology and Metabolism'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Aydogan Aydogdu', 'investigatorAffiliation': 'Gulhane School of Medicine'}}}}