Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies
Conditions
Keywords
Trimetazidine, Diastolic dysfunction, diabetes mellitus
Brief summary
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.
Interventions
Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily
DRUGPlacebo
Starch tablets used twice daily
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Left ventricular functions at 3 months | at baseline and after three months of intervention | assessed using echocardiographic and tissue doppler evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Tumor necrosis factor alpha at 3 months | at baseline and after three months of intervention | assessed using ELISA technique |
| Change from baseline Transforming growth factor beta 1 at 3 months | at baseline and after three months of intervention | assessed using ELISA technique |
Countries
Egypt
Contacts
Primary Contactheba I serag, Master
Outcome results
None listed