Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect Of Trimetazidine On Left Ventricular Functions and Inflammatory Markers of Patients With Type 2 Diabetes Mellitus
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. Therefore, 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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Age from 40-75 years 2. Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF =50% Exclusion Criteria: 1. Patients with valvular, congenital or ischemic heart disease. 2. Patients with inadequately controlled hypertension (blood pressure>140/90 mm Hg) 3. Patients with HbA1c% <10 % 4. Patients with history of intolerance or allergic response to TMZ 5. Patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance < 30 ml/min) 6. Patients with other significant comorbidities such as malignancy, significant psychiatric illness, autoimmune diseases. 7. Patients with Parkinson's disease or motor disorders 8. Pregnancy and breast feeding |
Country | Name | City | State |
---|---|---|---|
Egypt | Ainshams university hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline Left ventricular functions at 3 months | assessed using echocardiographic and tissue doppler evaluation | at baseline and after three months of intervention | |
Secondary | Change from baseline Tumor necrosis factor alpha at 3 months | assessed using ELISA technique | at baseline and after three months of intervention | |
Secondary | Change from baseline Transforming growth factor beta 1 at 3 months | assessed using ELISA technique | at baseline and after three months of intervention |
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