Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-27 @ 6:56 PM
Study NCT ID:
NCT02183558
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2014-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for GDM in Women With PCOS and Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}], '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': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational diabetes mellitus', 'timeFrame': '2 years', 'description': 'Gestational diabetes mellitus diagnosed by oral glucose tolerance test in gestational week 28 in women with and without risk factors for gestational diabetes mellitus.'}, {'measure': 'Gestational Diabetes Mellitus', 'timeFrame': 'Gestational week 28', 'description': 'Gestational diabetes mellitus is diagnosed by 2 hour 75 gram oral glucose tolerance test in gestational week 28'}], 'secondaryOutcomes': [{'measure': 'Anthropometric measures in offspring', 'timeFrame': 'At birth', 'description': 'The association between blood glucose values and anthropometric measures (birth length, weight and abdominal circumference) at birth in the offspring is investigated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCOS', 'GDM', 'OGTT', 'Glucose metabolism'], 'conditions': ['Polycystic Ovary Syndrome', 'Gestational Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '40611483', 'type': 'DERIVED', 'citation': 'Al-Jorani H, Jensen RC, Jensen TK, Christesen HT, Jorgensen JS, Bacmeister L, Dechend R, Glintborg D, Jensen BL, Andersen MS. Diurnal Urinary Aldosterone Excretion and Potassium Intake During Pregnancy Are Associated With High Normal Blood Pressure in Early Childhood. J Am Heart Assoc. 2025 Jul 15;14(14):eJAHA2025042165T. doi: 10.1161/JAHA.124.042165. Epub 2025 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy, insulin sensitivity decreases. The investigators examine glucose metabolism during oral glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective cohort of pregnant women with PCOS and controls.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy achieved during 2010-2012\n* Residents of the municipality of Odense\n\nExclusion Criteria:\n\n* Moving from Odense during pregnancy'}, 'identificationModule': {'nctId': 'NCT02183558', 'briefTitle': 'Screening for GDM in Women With PCOS and Controls', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Glucose Metabolism and Screening for Gestational Diabetes Mellitus According to Different Sets of Criteria in Women With Polycystic Ovary Syndrome and Controls', 'orgStudyIdInfo': {'id': 'GDM OBK'}, 'secondaryIdInfos': [{'id': 'Glucose OBK', 'type': 'OTHER', 'domain': 'Odense University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OGTT by randomization', 'description': 'Women without risk factors for GDM are offered OGTT in gestational week 28', 'interventionNames': ['Other: OGTT by randomization']}, {'type': 'EXPERIMENTAL', 'label': 'OGTT by indication', 'description': 'Women with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28', 'interventionNames': ['Other: OGTT by indication']}], 'interventions': [{'name': 'OGTT by randomization', 'type': 'OTHER', 'armGroupLabels': ['OGTT by randomization']}, {'name': 'OGTT by indication', 'type': 'OTHER', 'armGroupLabels': ['OGTT by indication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'country': 'Denmark', 'facility': 'OdenseUH', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Marianne Andersen, DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'Municipality of Odense', 'class': 'OTHER_GOV'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DMSci', 'investigatorFullName': 'Marianne Andersen', 'investigatorAffiliation': 'Odense University Hospital'}}}}