Efficacy of Trimetazidine in Diabetic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect Of Trimetazidine On Left Ventricular Functions and Inflammatory Markers of Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies

Intervention / Treatment
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* Drug: Trimetazidine Dihydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 40-75 years Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF ≥50% Exclusion Criteria: Patients with valvular, congenital or ischemic heart disease. Patients with inadequately controlled hypertension (blood pressure>140/90 mm Hg) Patients with HbA1c% <10 % Patients with history of intolerance or allergic response to TMZ Patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance < 30 ml/min) Patients with other significant comorbidities such as malignancy, significant psychiatric illness, autoimmune diseases. Patients with Parkinson's disease or motor disorders Pregnancy and breast feeding

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Patients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months. | Drug: Trimetazidine Dihydrochloride<br>* Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily<br>* Other names: Vasteral mr;|
| Placebo Comparator: Group 2<br>Patients will receive Placebo tablet twice daily in addition to their standard treatment for three months. | Drug: Placebo<br>* Starch tablets used twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Tumor necrosis factor alpha at 3 months | assessed using ELISA technique | at baseline and after three months of intervention | 
| Change from baseline Transforming growth factor beta 1 at 3 months | assessed using ELISA technique | at baseline and after three months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trimetazidine, Diastolic dysfunction, diabetes mellitus