Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-03 @ 12:41 AM
Study NCT ID:
NCT02676518
Status:
UNKNOWN
Last Update Posted:
2016-02-08
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMH, Glucose Intolerance and Metabolic Syndrome in PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-11-17', 'releaseDate': '2016-09-28'}], 'estimatedResultsFirstSubmitDate': '2016-09-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D024821', 'term': 'Metabolic 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'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* Serum anti-mullerian hormone level\n* Blood test for 2-hours 75 gram glucose tolerance test\n* Blood tests for total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences between serum AMH level between PCOS women with and without glucose intolerance and metabolic syndrome', 'timeFrame': '6 months', 'description': 'Any differences between mean of serum AMH levels in PCOS with and without glucose intolerance and metabolic syndrome'}], 'secondaryOutcomes': [{'measure': 'Percentage of glucose intolerance in PCOS women', 'timeFrame': '6 months', 'description': 'Percentage of glucose intolerance detected by 75 g OGTT in PCOS women'}, {'measure': 'Percentage of metabolic syndrome in PCOS women', 'timeFrame': '6 months', 'description': 'Percentage of metabolic syndrome defined by the Harmonized criteria in PCOS women'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['polycystic ovary syndrome', 'Serum anti-Mullerian hormone', 'glucose intolerance', 'metabolic syndrome'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)', 'detailedDescription': '* To study the association between serum anti-Mullerian hormone (AMH) level and glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS).\n* Glucose intolerance is detected by 2-hours 75 gram oral glucose tolerance test (OGTT).\n* Metabolic syndrome is diagnosed by using the Harmonized criteria; the presence of any 3 of 5 following risk factors constitutes a diagnosis of metabolic syndrome.\n\n 1. Elevated waist circumference (\\> 80 cm in Asian women)\n 2. Elevated triglycerides (\\> 150 mg/dL)\n 3. Reduced HDL-cholesterol (\\< 50 mg/dL)\n 4. Elevated blood pressure )systolic \\> 130 and/or diastolic \\> 85 mmHg)\n 5. Elevated fasting glucose ( \\> 100 mg/dL)\n* Percentage of glucose intolerance and metabolic syndrome in PCOS women as well was any differences in parameters between PCOS patients with and without glucose intolerance and metabolic syndrome will be analysed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Thai women with PCOS diagnosed by Rotterdam criteria 2003 who visit at Gynecological Department, King Chulalongkorn Memorial Hospital, Bangkok,Thailand', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCOS diagnosed by Rotterdam criteria 2003\n\nExclusion Criteria:\n\n* Pregnancy\n* Previous any hormonal uses in the last 3 months\n* Previous hypoglycemic drugs or insulin-sensitising agents use in the last 3 months\n* Previous chemotherapy, ovarian surgery, pelvic irradiation\n* Menopause'}, 'identificationModule': {'nctId': 'NCT02676518', 'briefTitle': 'AMH, Glucose Intolerance and Metabolic Syndrome in PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Anti-Müllerian Hormone and Its Association With Glucose Intolerance and Metabolic Syndrome in Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': '057/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'polycystic ovary syndrome women', 'description': 'PCOS women diagnosed by Rotterdam criteria visiting the Gynecologic Unit at King Chulalongkorn Memorial Hospital and meet the inclusion criteria and no exclusion criteria of the study', 'interventionNames': ['Other: serum']}], 'interventions': [{'name': 'serum', 'type': 'OTHER', 'description': 'Serum for serum anti-Mullerian hormone, 2-hour 75 gram oral glucose tolerance test and lipid profiles', 'armGroupLabels': ['polycystic ovary syndrome women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Wasamon Tunsuparp, MD', 'role': 'CONTACT', 'email': 'wasamontun@gmail.com'}, {'name': 'Porntip Sirayapiwat, MD, MSc', 'role': 'CONTACT', 'email': 'p_siraya@hotmail.com'}, {'name': 'Wasamon Tunsuparp, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Porntip Sirayapiwat, MD, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patchaya Boonchayaanant, MD, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Wasamon Tunsuparp, MD', 'role': 'CONTACT', 'email': 'wasamontun@gmail.com', 'phone': '66850658502'}, {'name': 'Porntip Sirayapiwat, MD, MSc', 'role': 'CONTACT', 'email': 'p_siraya@hotmail.com', 'phone': '66818378923'}], 'overallOfficials': [{'name': 'Dhirapong Charoenvidya, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Porntip Sirayapiwat', 'investigatorAffiliation': 'Chulalongkorn University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-09-28', 'type': 'RELEASE'}, {'date': '2016-11-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Porntip Sirayapiwat, Principal Investigator, Chulalongkorn University'}}}}