Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-31 @ 10:50 AM
Study NCT ID:
NCT06825533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-25
First Post:
2025-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prevalence of Prediabetes in Primary Care Medicine in Tunisia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-08-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2025-02-09', 'studyFirstSubmitQcDate': '2025-02-09', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediabetes', 'timeFrame': 'At inclusion', 'description': 'Percentage of prediabetic patients discovered at inclusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prediabetes', 'STMGF', 'Survey'], 'conditions': ['Prediabetes']}, 'descriptionModule': {'briefSummary': 'The study is national, observational and cross-sectional and aims to estimate the prevalence of prediabetes in primary care in Tunisia.', 'detailedDescription': 'TN-PREDIAB is a Tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in primary care facilities, of both public and private sectors. The study will screen ambulatory patients for at least 4 months to estimate the prevalence of prediabetes among enrolled subjects.\n\nThe objectives of the study are:\n\n* Primary objective: to estimate the overall prevalence of prediabetes among Tunisian population\n* Secondary objective:\n* Describe the clinical and epidemiological profile of prediabetic subjects\n* Describe nutritional factors associated with prediabetes\n\nA Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project.\n\nCollected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ambulatory patient consulting in primary care in a public or private structure, without patent diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory patient consulting in primary care in a public or private structure\n\nExclusion Criteria:\n\n* Known diabetes\n* Concomitant medication that may influence blood sugar (corticosteroids, metformin, GLP1 analogues, SGLT2 inhibitor)\n* Severe, acute or chronic comorbidity (end-stage renal failure, severe liver disease, heart failure)\n* Severe anemia\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06825533', 'acronym': 'TUN-PREDIAB', 'briefTitle': 'The Prevalence of Prediabetes in Primary Care Medicine in Tunisia', 'organization': {'class': 'OTHER', 'fullName': 'Dacima Consulting'}, 'officialTitle': 'The Prevalence of Prediabetes in Primary Care Medicine in Tunisia. a National Descriptive Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'DAC-016-TUN-PREDIAB'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fasting blood sugar level', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assess the level of Blood sugar level in fasting conditions at inclusion'}, {'name': 'Glycated hemoglobin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assess the level of glycated hemoglobin at inclusion'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Haithen Ben Haj Salah, MD', 'role': 'CONTACT', 'email': 'haithembelhaj@yahoo.fr', 'phone': '+216 52 988 183'}, {'name': 'Habib Jerbi, MD', 'role': 'CONTACT', 'email': 'drjerbi@yahoo.fr', 'phone': '+216 98 401 188'}], 'overallOfficials': [{'name': 'Mohamed Haithem Ben Haj Salah, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Société Tunisienne de Médecine Générale et de Médecine de Famille'}, {'name': 'Habib Jerbi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Société Tunisienne de Médecine Générale et de Médecine de Famille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dacima Consulting', 'class': 'OTHER'}, 'collaborators': [{'name': 'Société Tunisienne de Médecine Générale et de Médecine de Famille', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}