Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-01-04 @ 11:29 AM
Study NCT ID:
NCT02869750
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2016-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Adipokines, Obesity and Insulin Resistance in Women 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'BLOOD SAMPLE'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-30', 'studyFirstSubmitDate': '2016-08-05', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum ghrelin level', 'timeFrame': '24 hours', 'description': 'measuring ghrelin, and ) in the three groups'}, {'measure': 'serum resistin level', 'timeFrame': '24 hours', 'description': 'serum resistin level in the three groups'}, {'measure': 'serum adiponectin level', 'timeFrame': '24 hours', 'description': 'serum adiponectin level in the three groups'}], 'secondaryOutcomes': [{'measure': 'Glucose/Insulin ratio', 'timeFrame': '24 hours', 'description': 'fasting glucose and insulin in three groups'}, {'measure': 'serum testosterone level', 'timeFrame': '24 hours after labor', 'description': 'serum testosterone level in three groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovarian Syndrome']}, 'descriptionModule': {'briefSummary': 'To evaluate possible clinical effects of adipokines , ( ghrelin, resistin and adiponectin), in obese and non-obese patients with polycystic ovary syndrome (PCOS).', 'detailedDescription': 'Seventy selected PCOS patients will be recruited for this study, and will be divided into two groups based on their body mass index (BMI): 35 obese (BMI≥ 25 kg/m2, group A), 35 non-obese (BMI\\<25 kg/m2, group B). In addition, 35 healthy non-obese women (BMI\\<25 kg/m2) will bw enrolled as the control (group C). Serum levels of FSH (follicle stimulating hormone), LH (luteinizing hormone), T(testosterone), glucose, insulin, adiponectin, resistin and resistin will bw detected, and compared the differences of them among three groups'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Females with PCOS in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females with PCOS in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital\n\nExclusion Criteria:\n\n* Known androgen secreting tumor.\n* PCO on ovarian stimulation medications\n* PCO with any other medical illness.'}, 'identificationModule': {'nctId': 'NCT02869750', 'briefTitle': 'The Relationship Between Adipokines, Obesity and Insulin Resistance in Women With Polycystic Ovarian Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of Adipokines ( Ghrelin, Resistin and Adiponectin), in Egyptian Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'ADIPCOS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese PCOS', 'description': 'PCOS patients with BMI more than 25 kg/m2'}, {'label': 'Lean PCOS', 'description': 'PCOS patients with BMI less than 25 kg/m2'}, {'label': 'PCOS with normal HOMA2-1R', 'description': 'PCOS without Insuline resistance'}, {'label': 'PCOS with elevated HOMA2-IR', 'description': 'PCOS with Insuline resistance'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Kotb', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in obstertics and gynecology, Ain Shams University Hospital', 'investigatorFullName': 'Ahmed Mohamed El Kotb Abdel Fattah', 'investigatorAffiliation': 'Ain Shams University'}}}}