Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-29 @ 3:56 AM
Study NCT ID:
NCT01623934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-18
First Post:
2012-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'maternal and child plasma, whole cord blood, serum/plasma cord blood, maternal and child white cells, placenta, maternal and child urine, child saliva, maternal and child stool, child hair'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1034}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2012-06-18', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of gestational diabetes mellitus', 'timeFrame': '24-28 weeks of gestation', 'description': '75g oral glucose tolerance test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational diabetes', 'Adiponectin', 'Leptin', 'Single Nucleotides Polymorphisms', 'Insulin resistance', 'obesity'], 'conditions': ['Gestational Diabetes', 'Insulin Resistance', 'Obesity Prevention']}, 'referencesModule': {'references': [{'pmid': '26842272', 'type': 'DERIVED', 'citation': 'Guillemette L, Allard C, Lacroix M, Patenaude J, Battista MC, Doyon M, Moreau J, Menard J, Bouchard L, Ardilouze JL, Perron P, Hivert MF. Genetics of Glucose regulation in Gestation and Growth (Gen3G): a prospective prebirth cohort of mother-child pairs in Sherbrooke, Canada. BMJ Open. 2016 Feb 3;6(2):e010031. doi: 10.1136/bmjopen-2015-010031.'}]}, 'descriptionModule': {'briefSummary': 'This study includes 2 phases. During phase 1, pregnant women are followed over the course of pregnancy. The phase 2 is a follow-up of the mother-child dyad at 3, 5 and 10-12 year after delivery.\n\nThe purpose of this phase 1 is to :\n\n* assess the contribution and interactions of adipokines in the development of insulin resistance during pregnancy and gestational diabetes;\n* assess levels of maternal adipokines as determinants of development and fetal growth;\n* determine the genetic variations that influence levels of adipokines and glucose regulation during pregnancy and in newborns.\n\nThe purpose of this phase 2 is to:\n\n* identify DNA methylation variations at birth that are predictive of childhood overweight/obesity.\n* identify maternal characteristics associated with DNA methylation variations predictive of childhood overweight/obesity.\n* establish whether the loci predictive of childhood overweight/obesity at birth are still differentially methylated at 5 years of age (samples collected at 5 years of age).\n* identify DNA methylation variations at birth that are predictive of childhood neurodevelopment problems at 3, 5 and 10 years of age.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Phase 1: Pregnant women when they come for their first prenatal visit at the Clinique de Prélèvements et de Recherche en Grossesse.\n\nPhase 2: mothers and their child', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 yrs\n* gestational age between 6 and 13 weeks from last menstrual period\n* no recognized diabetes or drugs interfering with glucose metabolism\n* alcohol \\< 2 drinks/day\n* not involved in regular high intensity physical activity\n* otherwise good health status\n\nExclusion Criteria:\n\n* twin pregnancy'}, 'identificationModule': {'nctId': 'NCT01623934', 'acronym': 'GEN3G', 'briefTitle': 'Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development', 'orgStudyIdInfo': {'id': 'GEN3G'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1: Pregnant women'}, {'label': 'Phase 2: Mother-offspring dyad'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Marie-France Hivert, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School, Harvard Prilgrim Health Care Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'American Diabetes Association', 'class': 'OTHER'}, {'name': 'Diabetes Québec', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md, MMSc', 'investigatorFullName': 'Marie-France Hivert', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}