Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT05556005
Status:
UNKNOWN
Last Update Posted:
2022-09-27
First Post:
2022-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Trimetazidine in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D058065', 'term': 'Diabetic Cardiomyopathies'}, {'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'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014292', 'term': 'Trimetazidine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Left ventricular functions at 3 months', 'timeFrame': 'at baseline and after three months of intervention', 'description': 'assessed using echocardiographic and tissue doppler evaluation'}], 'secondaryOutcomes': [{'measure': 'Change from baseline Tumor necrosis factor alpha at 3 months', 'timeFrame': 'at baseline and after three months of intervention', 'description': 'assessed using ELISA technique'}, {'measure': 'Change from baseline Transforming growth factor beta 1 at 3 months', 'timeFrame': 'at baseline and after three months of intervention', 'description': 'assessed using ELISA technique'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trimetazidine', 'Diastolic dysfunction', 'diabetes mellitus'], 'conditions': ['Diabetes Mellitus, Type 2', 'Diabetic Cardiomyopathies']}, 'referencesModule': {'references': [{'pmid': '39814796', 'type': 'DERIVED', 'citation': 'Serag H, Wakeel LE, William V, Abdelsalam M, Abdelsalam A, Sayed R. Effect of trimetazidine on left ventricular functions and cardiac biomarkers in diabetic patients with left ventricular diastolic dysfunction: a randomized controlled trial. Sci Rep. 2025 Jan 16;15(1):2115. doi: 10.1038/s41598-024-83213-w.'}]}, 'descriptionModule': {'briefSummary': 'Subclinical diastolic dysfunction represents the early phase of diabetic cardiomyopathy and is a common complication among type 2 diabetic patients that increases mortality rate among those patients and can progress to heart failure with preserved ejection fraction. Trimetazidine is an anti-ischemic agent widely used in the treatment of coronary artery disease and it has positive effects on energy metabolism in heart failure.\n\nTherefore, we hypothesized that trimetazidine may have potential benefit on the amelioration of the inflammatory insult and improving the clinical outcomes in patients with diabetic cardiomyopathy especially if applied in the early stages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age from 40-75 years\n2. Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF ≥50%\n\nExclusion Criteria:\n\n1. Patients with valvular, congenital or ischemic heart disease.\n2. Patients with inadequately controlled hypertension (blood pressure\\>140/90 mm Hg)\n3. Patients with HbA1c% \\<10 %\n4. Patients with history of intolerance or allergic response to TMZ\n5. Patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance \\< 30 ml/min)\n6. Patients with other significant comorbidities such as malignancy, significant psychiatric illness, autoimmune diseases.\n7. Patients with Parkinson's disease or motor disorders\n8. Pregnancy and breast feeding"}, 'identificationModule': {'nctId': 'NCT05556005', 'briefTitle': 'Efficacy of Trimetazidine in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect Of Trimetazidine On Left Ventricular Functions and Inflammatory Markers of Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'RHDIRB2020110301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Patients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months.', 'interventionNames': ['Drug: Trimetazidine Dihydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'Patients will receive Placebo tablet twice daily in addition to their standard treatment for three months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Trimetazidine Dihydrochloride', 'type': 'DRUG', 'otherNames': ['Vasteral mr'], 'description': 'Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily', 'armGroupLabels': ['Group 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Starch tablets used twice daily', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'lamia El wakeel, Professor', 'role': 'CONTACT', 'email': 'Lamia.elwakeel@pharma.asu.edu.eg'}], 'facility': 'Ainshams university hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'heba I serag, Master', 'role': 'CONTACT', 'email': 'hebaibrahim92@pharm.asu.edu.eg', 'phone': '01008344689', 'phoneExt': '002'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of clinical pharmacy- faculty of pharmacy', 'investigatorFullName': 'Heba ibrahim Mohamed serag', 'investigatorAffiliation': 'Ain Shams University'}}}}