Efficacy of Trimetazidine in Diabetic Patients

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05556005

Collaborator

(none)

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Diabetic Cardiomyopathies	Drug: Trimetazidine Dihydrochloride Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 18, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Group 1

Patients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months.

Drug: Trimetazidine Dihydrochloride

Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily

Other Names:

Vasteral mr

Placebo Comparator: Group 2

Patients will receive Placebo tablet twice daily in addition to their standard treatment for three months.

Drug: Placebo

Starch tablets used twice daily

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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