Efficacy of Trimetazidine in Diabetic Patients

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556005
• Other study ID #: RHDIRB2020110301
• Status: Recruiting
• Phase: Phase 2
• Start date: September 18, 2022
• Est. completion date: September 2023

Study information

• Verified date: September 2022
• Source: Ain Shams University
• Contact: heba I serag, Master
• Phone: 01008344689
• Email: hebaibrahim92[@]pharm.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Cardiomyopathies

Intervention

Drug:
• Trimetazidine Dihydrochloride
Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily
• Placebo
Starch tablets used twice daily

Locations

Country	Name	City	State
Egypt	Ainshams university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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