Trimetazidine for Improved Left Ventricular Functions and Reduced Inflammation in Type 2 Diabetes Mellitus Patients
This study aims to evaluate the effectiveness of Trimetazidine in improving left ventricular heart functions and reducing inflammation in individuals with Type 2 Diabetes Mellitus, measured through echocardiographic and tissue doppler evaluation after 3 months of treatment.
Trimetazidine Dihydrochloride
+ Placebo
Cardiovascular Diseases+8
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Treatment Study
Summary
Study start date: September 18, 2022
Actual date on which the first participant was enrolled.This study focuses on patients with type 2 diabetes mellitus who often experience a common complication known as subclinical diastolic dysfunction. This condition is an early phase of diabetic cardiomyopathy, which can increase mortality rates and potentially lead to heart failure. The study aims to investigate the effects of Trimetazidine, a drug typically used to treat coronary artery disease, on this specific condition. Trimetazidine is known for its positive effects on energy metabolism in heart failure, and the hypothesis is that it may improve clinical outcomes for patients with diabetic cardiomyopathy, especially when applied in the early stages. During this phase 2 treatment study, participants will receive Trimetazidine. The study's primary outcome is to measure changes in left ventricular functions from the baseline after 3 months of treatment. These changes will be assessed using echocardiographic and tissue doppler evaluation, which are non-invasive methods to monitor heart function. The study aims to understand if Trimetazidine can improve heart health in patients with type 2 diabetes mellitus and subclinical diastolic dysfunction.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location