Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-07 @ 7:52 PM
Study NCT ID:
NCT01961466
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2013-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes and Psychological Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 592}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2013-10-10', 'studyFirstSubmitQcDate': '2013-10-10', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlations between glycemic balance (HbA1c) and the score on the Bortner self-questionnaire', 'timeFrame': 'At 1 year'}], 'secondaryOutcomes': [{'measure': 'Scores on the scales', 'timeFrame': 'At 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 or 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile evaluated by the Bortner self-questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 or 2 Diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have been given information about the research\n* patients with National Health Insurance\n* diabetic patients (type 1 or 2)\n* patients \\> 18 ans\n\nExclusion Criteria:\n\n* Adult patients under guardianship or intellectually dependent\n* patients without National Health Insurance'}, 'identificationModule': {'nctId': 'NCT01961466', 'acronym': 'DPP', 'briefTitle': 'Diabetes and Psychological Profile', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Prospective Study on the Influence of Psychosocial Variables (Stress, Type A Behaviour Pattern, Quality of Life of the Diabetic) on Glycemic Balance in Patients With Type 1 and 2 Diabetes.', 'orgStudyIdInfo': {'id': 'CHAUVET-GELINIER 2009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic patients', 'interventionNames': ['Other: psychological and social self-administered questionnaires']}], 'interventions': [{'name': 'psychological and social self-administered questionnaires', 'type': 'OTHER', 'armGroupLabels': ['Diabetic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}