Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT05567692
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2022-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subjects With T2D or at Risk of T2D Cohort Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 837}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2032-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type 2 diabetes incidence in Descendance population', 'timeFrame': '9years', 'description': 'Presence of type 2 diabetes mellitus, on basis of self-reported (physician diagnosis) or diagnosed by OGTT and HbA1c'}], 'secondaryOutcomes': [{'measure': 'Provide estimates of prevalence of diabetes and prediabetes in Descendance population', 'timeFrame': 'at baseline, 3-, 6- and 9-years follow-up', 'description': 'To estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in Descendance population'}, {'measure': 'Study of interactions between risk factors on type 2 diabetes incidence', 'timeFrame': 'at baseline, 3-, 6- and 9-years follow-up', 'description': 'Self-administered questionnaire. "Descendance" specific questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes ; Risk Prediction ; Prevention'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to prospectively follow the subjects included in "Descendance" cohort and to describe the occurrence of type 2 diabetes in non-diabetic subjects, which will allow us to iteratively update the "Descendance" Type 2 Diabetes risk prediction model.', 'detailedDescription': 'High risk families will be prospectively follow in order to better understand the risk of transmission of type 2 diabetes from one generation to another. The cohort will also allow us to collect additional data on diabetic patients.\n\nThe monitoring of the cohort will take place for at least 10 years with a follow-up of all participants every three years. To detect individuals who develop dysglycemia during the study, a glucose tolerance test (GTT) and HbA1c measurement will be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects included in the DESCENDANCE clinical trial (Id: NCT01727349) between 20011 and 2020, will be re-invited to participate in the Descendance cohort follow-up.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects have participated in the Descendance study\n* Subjets who sign informed consent to participate in the study\n\nExclusion Criteria:\n\n* Subjects not enrolled in Descendance study\n* Subjects refusing to participate\n* Pregnant or breastfeeding\n* Subjects in emergency situations, under legal protection or unable to provide informed -consent\n* Subjects lost to follow-up or died'}, 'identificationModule': {'nctId': 'NCT05567692', 'acronym': 'DESCENDANCE', 'briefTitle': 'Subjects With T2D or at Risk of T2D Cohort Follow-up', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète"}, 'officialTitle': 'Descendance Cohort: Follow-up of Subjects With Type 2 Diabetes or at Risk of Type 2 Diabetes Defined by the Existence of the Disease in the Family in Two Successive Generations', 'orgStudyIdInfo': {'id': '2022-A01538-35'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T2D group', 'description': 'subjects with type 2 diabetes', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Non-T2D group', 'description': 'healthy subjects', 'interventionNames': ['Diagnostic Test: OGTT', 'Other: HbA1c', 'Other: Questionnaire']}], 'interventions': [{'name': 'OGTT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Oral Glucose Tolerance Test', 'armGroupLabels': ['Non-T2D group']}, {'name': 'HbA1c', 'type': 'OTHER', 'description': 'HbA1c measurement', 'armGroupLabels': ['Non-T2D group']}, {'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Follow-up questionnaire', 'armGroupLabels': ['Non-T2D group', 'T2D group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91058', 'city': 'Évry', 'country': 'France', 'facility': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète", 'geoPoint': {'lat': 48.6328, 'lon': 2.44049}}], 'overallOfficials': [{'name': 'Guillaume CHARPENTIER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète", 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Pasteur de Lille', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}