Efficacy of Trimetazidine in Diabetic Patients

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies
• Interventions: Drug: Placebo; Drug: Trimetazidine Dihydrochloride

• Registration Number: NCT05556005
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-18
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Study First Posted: 2022-09-27
• Last Update Posted: 2022-09-27
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Placebo	Patients will receive Placebo tablet twice daily in addition to their standard treatment for three months.
Group 1	Trimetazidine Dihydrochloride	Patients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ainshams university hospitals; 🇪🇬 Cairo, Egypt