Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-02-17 @ 11:05 PM
Study NCT ID:
NCT01637727
Status:
UNKNOWN
Last Update Posted:
2012-07-13
First Post:
2012-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'the women will undergo a physical examination which will include measurements of blood pressure, height, weight and waist circumference.Blood samples will be obtained for evaluation of fasting glucose level, HbA1c, lipid profile and kidney functions.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 324}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-12', 'studyFirstSubmitDate': '2012-06-24', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term effects of gestational diabetes mellitus in a population of parous women', 'timeFrame': '24-32 months', 'description': 'The primary goal of this proposed research deals with estimating the risk of developing type 2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a history of GDM'}], 'secondaryOutcomes': [{'measure': 'Long term effects of gestational diabetes mellitus in a population of parous women', 'timeFrame': '24-32 months.', 'description': 'In addition, this study will attempt to evaluate the effect of parity on the late appearance of type 2 diabetes and metabolic syndrome in this unique population.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Long term effects of gestational diabetes mellitus in a population of parous women', 'Gestational diabetes mellitus- GDM is defined as glucose intolerance diagnosed during pregnancy and not present shortly after birth'], 'conditions': ['Gestational Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The primary goal of this proposed research deals with estimating the risk of developing type 2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a history of GDM. In addition, this study will attempt to evaluate the effect of parity on the late appearance of type 2 diabetes and metabolic syndrome in this unique population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The proposed research format is: a case control study using a historical cohort of women diagnosed with GDM. The study group will include women who gave birth in Shaare Zedek Medical Center between the years 2000 and 2010. Women with a GDM history will be identified based on the gestational diabetes clinic files. Women without a history of GDM who will be the control group will be identified from the Shaare Zedek Medical Center birth registration records', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study group will include women who gave birth in Shaare Zedek Medical Center between the years 2000 and 2010.\n* Women with a GDM history will be identified based on the gestational diabetes clinic files.\n* Women without a history of GDM who will be the control group will be identified from the Shaare Zedek Medical Center birth registration records\n\nExclusion Criteria:\n\n* We established the following exclusion criteria:\n\n * women who are diagnosed with metabolic syndrome before pregnancy or have type 1 or type 2 diabetes, and\n * women with severe chronic diseases.'}, 'identificationModule': {'nctId': 'NCT01637727', 'acronym': 'GDM', 'briefTitle': 'Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women', 'orgStudyIdInfo': {'id': 'GDM.CTIL'}, 'secondaryIdInfos': [{'id': 'GDM.CTIL'}, {'id': 'GDMLTE.10'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'GDM1', 'description': 'The study group will include women who gave birth in Shaare Zedek Medical Center between the years 2000 and 2010. Women with a GDM history will be identified based on the gestational diabetes clinic files. Women without a history of GDM who will be the control group will be identified from the Shaare Zedek Medical Center birth registration records.'}, {'label': 'GDM', 'description': 'The study group will include women who gave birth in Shaare Zedek Medical Center between the years 2000 and 2010. Women with a GDM history will be identified based on the gestational diabetes clinic files. Women without a history of GDM who will be the control group will be identified from the Shaare Zedek Medical Center birth registration records.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'state': 'Israel', 'country': 'Israel', 'contacts': [{'name': 'ORIT LAMM, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'SORINA GRISARO GRANOVSKY, DR', 'role': 'CONTACT', 'email': 'granovs@012.net.il', 'phone': '054-4385480'}, {'name': 'ORIT LAMM, MD', 'role': 'CONTACT', 'email': 'ADI.LAM@NB013.com', 'phone': '02-9934425', 'phoneExt': '02'}], 'overallOfficials': [{'name': 'Arnon Samueloff, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center'}, {'name': 'Sorina Grissaro Granovsky, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Shaare Zedek Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}