Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 1:01 AM
Study NCT ID:
NCT03644004
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2018-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Glucose Tolerance Test and Post Partum Diagnosis of Diabetes Mellitus, Type 2 (DT2 Post-Partum)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performing oral glucose tolerance test in order to detect type 2 diabetes', 'timeFrame': 'Month 6', 'description': 'Performing oral glucose tolerance test between 6 and 12 weeks after childbirth. As recommended by actual World Health Organisation (WHO) guidelines'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus, type 2, is a chronic disease which can be linked with many complications in connexion with impaired blood glucose balance.\n\nIt diagnosis in risky subjects such as in patients with medical history of gestational diabetes is therefore imperative to prevent its complications.\n\nActual guidelines recommend an oral tolerance glucose test, measuring glucose levels after oral glucose intake (75g), between 6 an 12 weeks after childbirth. But studies reveal a low diagnosis rate.\n\nThe study of the current practices of diagnosis methods seem to be essential in order to improve this diagnosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who develop a gestational diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients followed in endocrinology at the hospital of Vienne for gestational diabetes, whom benefited an educational therapy session between the 01/01/2016 and the 31/12/2016 inclusive.\n\nExclusion Criteria:\n\n* Minor patients or under legal protection (guardianship)\n* Patients who not speak french\n* Patients who did not declared an attending physician\n* Refusal to take part in the survey\n* Patients lost to follow-up before childbirth\n* Patients whose pregnancy ended by foetal death.\n* Pre-existing diabet before pregnancy'}, 'identificationModule': {'nctId': 'NCT03644004', 'briefTitle': 'Oral Glucose Tolerance Test and Post Partum Diagnosis of Diabetes Mellitus, Type 2 (DT2 Post-Partum)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Descriptive Study of the Diabetes Mellitus, Type 2 Diagnosis Methods During Postpartum Period in Patients With Medical History of Gestational Diabetes Whom Benefited an Educational Therapy Session.', 'orgStudyIdInfo': {'id': '69HCL18_0210'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with medical history of gestational diabetes', 'description': 'Patients followed at the hospital of Vienne for gestational diabetes in 2016.', 'interventionNames': ['Other: frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.']}], 'interventions': [{'name': 'frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.', 'type': 'OTHER', 'otherNames': ['Evaluate the frequency of diabetes mellitus, type 2, diagnosis with an oral glucose tolerance test between 6 and 12 weeks after childbirth in patients with medical history of gestational diabetes.'], 'description': "Patients will be contacted by mail with sending of the information notice to ask them to participate in the study.\n\nIf they don't reply, the subjects will be called by phone by the investigator to collect their non opposition of participation at the study.\n\nDuring this call, the investigator will be able to answer all the questions about the study.\n\nThe report of this telephone conversation will be register in the medical file of the patient.\n\nThen, we will collect informatic data from the hospital concerning the patients.\n\nAfter that they will be contacted by phone to answer a survey. Beside, another secure survey will be send by email to each patient's family doctor.\n\nTo finish, crossing data between those of the patients and the family doctor and anonymisation of the data.", 'armGroupLabels': ['Women with medical history of gestational diabetes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienne', 'country': 'France', 'facility': 'Centre hospitalier Lucien Hussel', 'geoPoint': {'lat': 45.52569, 'lon': 4.87484}}], 'overallOfficials': [{'name': 'Laura BOGENMANN, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier de Vienne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}