Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 2:55 PM
Study NCT ID:
NCT06071208
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevent Diabetic Kidney Disease Among Egyptians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2028-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevention of diabetic complications', 'timeFrame': '5 years', 'description': 'glomerular filtration rate will be measured at the beginning of the study and at the end'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Without Complication']}, 'descriptionModule': {'briefSummary': 'Study of the possibility to prevent the development of Diabetic kidney disease in type 2 diabetic patients', 'detailedDescription': 'Study of the possible role of the SGLT2 inhibitors to prevent the development of frank type2 DM among prediabetic candidates.\n\nStudy of the possible role of the SGLT2 inhibitors to prevent the development of diabetic complications, namely diabetic kidney disease, diabetic retinopathy and neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'diabetics aged 18 years and above,male or females will be subjected to assessment of kidney functions at the beginning of the study and at the end to assess possibility of protective effect of SGLT-2,assessmentof other diabetic complications will be done also. Prediabetics will subjected to same assessment also', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetics,prediabetics\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06071208', 'briefTitle': 'Prevent Diabetic Kidney Disease Among Egyptians', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'The National Plan To Prevent Diabetic Kidney Disease Among Egyptians: A Prospective Multicenter Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'VCG 6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases of study', 'description': 'Patients is diabetes whether recently discovered or long standing diabetes', 'interventionNames': ['Drug: Gliflozin']}, {'label': 'controls of study', 'description': 'prediabetics ,or patients with clinical manifestations of insulin resistance eg acanthosis negricans', 'interventionNames': ['Drug: Gliflozin']}], 'interventions': [{'name': 'Gliflozin', 'type': 'DRUG', 'description': 'to study whether the use of gliflozin prevented diabetic complications', 'armGroupLabels': ['cases of study', 'controls of study']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Fayed, MD', 'role': 'CONTACT', 'email': 'dr.fayed@gmail.com', 'phone': '+201142700904'}, {'name': 'Mohammed Hegazy, MD', 'role': 'CONTACT', 'email': 'mohammed.hegazy@ngu.edu.eg/', 'phone': '+201205408765'}], 'overallOfficials': [{'name': 'Usama Sharaf El Din, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}, {'name': 'NewGiza University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of internal medicine', 'investigatorFullName': 'Ahmed Abdelkawi Hammad', 'investigatorAffiliation': 'Fayoum University'}}}}