Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT03573102
Status:
UNKNOWN
Last Update Posted:
2020-04-21
First Post:
2018-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Sodium Glucose co Transporter 2 Inhibitor ( SGLT2) on Proteinuria in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-07-08', 'releaseDate': '2020-06-23'}, {'resetDate': '2020-08-03', 'releaseDate': '2020-07-19'}], 'estimatedResultsFirstSubmitDate': '2020-06-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase 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'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-18', 'studyFirstSubmitDate': '2018-03-12', 'studyFirstSubmitQcDate': '2018-06-27', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'decrease in proteinuria', 'timeFrame': '6 months', 'description': 'improvement of proteinuria in patients receiving dapagliflozine'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['proteinuria , SGLT2 inhibitors , diabetes'], 'conditions': ['Diabetic Nephropathies']}, 'referencesModule': {'references': [{'pmid': '26472574', 'type': 'BACKGROUND', 'citation': 'Lotfy M, Adeghate J, Kalasz H, Singh J, Adeghate E. Chronic Complications of Diabetes Mellitus: A Mini Review. Curr Diabetes Rev. 2017;13(1):3-10. doi: 10.2174/1573399812666151016101622.'}]}, 'descriptionModule': {'briefSummary': 'Diabetes Mellitus is the leading cause of end stage renal disease. As proven by many studies , controlling proteinuria can delay the progression to end stage renal disease.This work will study the effect of sodium glucose co transporter 2 inhibitor , a new antihyperglycemic drug , on proteinuria and to compare its effect with the effect of classic antiproteinuric drugs as angiotensin converting enzyme inhibitor , aspirin and statins.', 'detailedDescription': 'Diabetic nephropathy involves progressive stages including glomerular hyperfilteration , microalbuminuria , overt proteinuria and a decline in glomerular filteration rate leading to end stage renal disease.\n\nDespite all the available interventions available for diabetic patients including tight glycemic control , and blood pressure control , using angiotensin converting enzyme inhibitors, angiotensin II receptor antagonist renal disease remains prevalent and progress in these patients.\n\nThe newer therapy of diabetes is the use of sodium glucose cotransporter 2 inhibitor as it has the potential of renoprotection in patients with diabetic nephropathy just as ACEI and ARBS to reduce glomerular hyperfilteration .This action may reduce albuminuria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with type 2 diabetes.\n* controlled diabetes.\n* patients with proteinuria\n\nExclusion Criteria:\n\n* patients with proteinuria due to other disease.\n* patients with HbA1c \\>8%.\n* patients with uncontrolled hypertension.\n* patients with chronic liver disease.\n* patients with type 1 diabetes .\n* patients already on the same drug ( dapagliflozine).\n* patients with raised serum creatinine.'}, 'identificationModule': {'nctId': 'NCT03573102', 'briefTitle': 'Effect of Sodium Glucose co Transporter 2 Inhibitor ( SGLT2) on Proteinuria in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of SGLT2 Inhibitor on Proteinuria in Diabetic Patients', 'orgStudyIdInfo': {'id': 'SGLT2 antiproteinuric effect'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'ACE inhibitor , aspirin , statins will be given once daily', 'interventionNames': ['Drug: ACE inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'cases', 'description': 'SGLT2 inhibitors will be given with classic antiproteinuric drugs', 'interventionNames': ['Drug: SGLT2 inhibitor', 'Drug: ACE inhibitor']}], 'interventions': [{'name': 'SGLT2 inhibitor', 'type': 'DRUG', 'otherNames': ['ACE Inhibitor'], 'description': 'SGLT2 inhibitor 10 mg/day', 'armGroupLabels': ['cases']}, {'name': 'ACE inhibitor', 'type': 'DRUG', 'otherNames': ['Aspirin , statins'], 'description': 'ACE inhibitor once daily', 'armGroupLabels': ['cases', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nahla H Tohami, MD', 'role': 'CONTACT', 'email': 'dr.nahlahussein@gmail.com', 'phone': '1003771280'}, {'name': 'Magdy Mohamed Saeed El Sharkawy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Magdy Sharkawy, MD', 'role': 'CONTACT', 'email': 'magdi35@hotmail.com', 'phone': '00201001422331'}, {'name': 'Nahla H Tohami, MSc', 'role': 'CONTACT', 'email': 'nahlatohami@med.asu.edu.eg', 'phone': '00201003771280'}], 'overallOfficials': [{'name': 'Magdy Sharkawy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nahla H Tohami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistent lecturer of nephrology', 'investigatorFullName': 'Nahla H Tohami', 'investigatorAffiliation': 'Ain Shams University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-06-23', 'type': 'RELEASE'}, {'date': '2020-07-08', 'type': 'RESET'}, {'date': '2020-07-19', 'type': 'RELEASE'}, {'date': '2020-08-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nahla H Tohami, Assistent lecturer of nephrology, Ain Shams University'}}}}