Efficacy of Trimetazidine in Diabetic Patients

September 26, 2022 updated by: Heba ibrahim Mohamed serag, Ain Shams University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Left ventricular functions at 3 months
Time Frame: at baseline and after three months of intervention
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
Time Frame: at baseline and after three months of intervention
assessed using ELISA technique
at baseline and after three months of intervention
Change from baseline Transforming growth factor beta 1 at 3 months
Time Frame: at baseline and after three months of intervention
assessed using ELISA technique
at baseline and after three months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHDIRB2020110301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Trimetazidine Dihydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe