Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-01-24 @ 8:10 AM
Study NCT ID:
NCT02583061
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2015-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toronto Gestational Glucose Tolerance Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'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'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011247', 'term': 'Pregnancy'}], 'ancestors': [{'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2015-10-20', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose tolerance status', 'timeFrame': '10 years after pregnancy', 'description': 'Glucose tolerance is assessed on oral glucose tolerance test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes, Gestational Diabetes, Pre-diabetes']}, 'descriptionModule': {'briefSummary': 'In this prospective observational cohort study, women representing the full spectrum of gestational glucose tolerance status are undergoing longitudinal cardiometabolic characterization at regular intervals in the years after the index pregnancy.', 'detailedDescription': 'In this prospective observational cohort study, women reflecting the full spectrum of glucose tolerance in pregnancy (from gestational diabetes mellitus (GDM) to lesser degrees of gestational glucose intolerance to those with completely normal glucose tolerance) are being recruited in late 2nd trimester. This cohort of women thus carries a broad range of risk for the future development of type 2 diabetes (T2DM) and cardiovascular disease. At regular intervals in the years after the index pregnancy, this cohort of women is undergoing serial cardiometabolic characterization, including assessment of glucose tolerance, beta-cell function and insulin sensitivity. The longitudinal changes over time in this cohort should provide insight into the early pathophysiology and natural history of T2DM and cardiovascular disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of pregnant women across the full spectrum of gestational glucose tolerance', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women\n\nExclusion Criteria:\n\n* Pre-existing diabetes before the index pregnancy'}, 'identificationModule': {'nctId': 'NCT02583061', 'briefTitle': 'Toronto Gestational Glucose Tolerance Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Toronto Gestational Glucose Tolerance Cohort', 'orgStudyIdInfo': {'id': '01-0318-E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'There is no intervention. An exposure of interest is glucose tolerance status in pregnancy', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1X5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ravi Retnakaran, MD', 'role': 'CONTACT', 'email': 'ravi.retnakaran@SinaiHealth.ca', 'phone': '416-586-4800', 'phoneExt': '3941'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Ravi Retnakaran, MD', 'role': 'CONTACT', 'email': 'ravi.retnakaran@sinaihealth.ca', 'phone': '416-586-4800', 'phoneExt': '3941'}], 'overallOfficials': [{'name': 'Ravi Retnakaran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}