Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-08 @ 2:41 AM
Study NCT ID:
NCT03660293
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2018-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D002216', 'term': 'Captopril'}, {'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011392', 'term': 'Proline'}, {'id': 'D007098', 'term': 'Imino Acids'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-14', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.', 'timeFrame': 'before and after 4 months of receiving cardio-protective agents', 'description': 'Corrected QT interval(QTc) and QT dispersion in ElectroCardioGram'}, {'measure': 'The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.', 'timeFrame': 'before and after 4 months of receiving cardio-protective agents', 'description': 'Left Ventricular End Systolic Volume (ml). Left Ventricular End Diastolic Volume (ml). Ejection Fraction (EF %) and left ventricular strain using echocardiography.'}], 'secondaryOutcomes': [{'measure': 'The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.', 'timeFrame': 'first day', 'description': 'Serum Cardiac troponin I by Enzyme Linked ImmunoSorbant Assay'}, {'measure': 'The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction', 'timeFrame': 'first day', 'description': 'Echocardiography'}, {'measure': 'Identification of risk factors for developing diabetic cardiac insult.', 'timeFrame': 'first day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '33536102', 'type': 'DERIVED', 'citation': 'Badreldeen A, El Razaky O, Erfan A, El-Bendary A, El Amrousy D. Comparative study of the efficacy of captopril, simvastatin, and L-carnitine as cardioprotective drugs in children with type 1 diabetes mellitus: a randomised controlled trial. Cardiol Young. 2021 Aug;31(8):1315-1322. doi: 10.1017/S1047951121000226. Epub 2021 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'Diabetic cardiomyopathy (DCM) is a distinct clinical entity of diabetic heart muscle that describes diabetes associated changes in the structure and function of the myocardium in the absence of coronary artery disease, hypertension, and valvular disease. Oxidative stress plays a critical role in DCM development. DCM can be diagnosed using the novel methods of echocardiography (tissue Doppler imaging, Speckling tracking techniques and more recent real time 4D echocardiography). There is a possible cardioprotective effect of statins, Captopril and L-Carnitine in type 1 diabetic children and adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescent suffering from type 1 Diabetes Mellitus, for at least 3 years from the onset of the disease.\n\nExclusion Criteria:\n\n* Children with Congenital Heart Diseases.\n* Children with acquired cardiac diseases.\n* Children with other systemic diseases.\n* Symptomatic diabetic cardiomyopathy.'}, 'identificationModule': {'nctId': 'NCT03660293', 'briefTitle': 'Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardio-protective Drugs', 'orgStudyIdInfo': {'id': '31499/04/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'diabetic- no cardioprotectives', 'description': '25 child with type 1 diabetes mellitus will not receive any cardio protective drug'}, {'type': 'EXPERIMENTAL', 'label': 'diabetic-Atorvastatin', 'description': '25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day)', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'diabetic-Captopril', 'description': '25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day)', 'interventionNames': ['Drug: Captopril']}, {'type': 'EXPERIMENTAL', 'label': 'diabetic-L-Carnitine', 'description': '25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day)', 'interventionNames': ['Drug: L-carnitine']}, {'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': '50 healthy children, of matched age and sex, with no symptoms of cardiac diseases'}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'cardio-protective agents', 'armGroupLabels': ['diabetic-Atorvastatin']}, {'name': 'Captopril', 'type': 'DRUG', 'description': 'cardio-protective agents', 'armGroupLabels': ['diabetic-Captopril']}, {'name': 'L-carnitine', 'type': 'DRUG', 'description': 'cardio-protective agents', 'armGroupLabels': ['diabetic-L-Carnitine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine- Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Professor of Pediatrics', 'investigatorFullName': 'Rasha Mohamed Gamal', 'investigatorAffiliation': 'Tanta University'}}}}