Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-21 @ 8:30 AM
Study NCT ID:
NCT04020068
Status:
UNKNOWN
Last Update Posted:
2019-07-15
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes Cohort in French Amazonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-05-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-12', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of patient care', 'timeFrame': '2 years', 'description': 'Number of health complications in diabetes mellitus ...'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabete', 'French Guiana'], 'conditions': ['Diabetes Mellitus', 'Adults']}, 'descriptionModule': {'briefSummary': 'CoDiAm aims to collect clinical, biological and social data of diabetic patients in French Guiana.', 'detailedDescription': "Diabetes is a very common disease in French Guiana. This disease is caused by the body's inability to metabolise sugar properly. A diet and treatment with tablets are enough for some patients, while others may need insulin injections. In the long term, high blood sugar levels may cause problems to the small and large blood vessels in the body. This is complicated by nerve, renal and retinal damage, as well as increased risks of cardiac and vascular events (such as strokes or heart attacks.) It appears that diabetes is more common and more severe in French Guiana than in other parts of France. It seems that the types of diabetes found here are more variable than those found in France, and that patients tend to be diagnosed at a later stage. We would this like to better understand diabetes and its evolution in French Guiana.\n\nThis research is aimed at diabetic patients and it is being carried out in the Andrée Rosemon Hospital Centre, the Ouest Guyanais Hospital Centre as well as in other Primary Healthcare Centres. At some point in the future, some private health centres may also invite their patients to take part in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic patients living in French Guiana', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with diabetes\n* At least 18 years old\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Patients under legal guardianship\n* Patients' refusal to participate\n* Patients living outside French Guiana"}, 'identificationModule': {'nctId': 'NCT04020068', 'acronym': 'CoDiAm', 'briefTitle': 'Diabetes Cohort in French Amazonia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Cayenne'}, 'officialTitle': 'Diabetes Cohort in French Amazonia', 'orgStudyIdInfo': {'id': 'CODIAM'}}, 'contactsLocationsModule': {'locations': [{'zip': '97306', 'city': 'Cayenne', 'state': 'French Guiana', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu Nacher, MD, PhD', 'role': 'CONTACT', 'email': 'mathieu.nacher@ch-cayenne.fr', 'phone': '+594594395024', 'phoneExt': '5024'}, {'name': 'DRCI CAYENNE', 'role': 'CONTACT', 'email': 'cicec@ch-cayenne.fr', 'phone': '+5945945385'}, {'name': 'Nadia SABBAH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Cayenne'}], 'centralContacts': [{'name': 'Nadia SABBAH, MD', 'role': 'CONTACT', 'email': 'nadia.sabbah@ch-cayenne.fr', 'phone': '+594594394150'}, {'name': 'DRCI CAYENNE', 'role': 'CONTACT', 'email': 'cicec@ch-cayenne.fr', 'phone': '+594594395385'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Cayenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}