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Efficacy of Trimetazidine in Diabetic Patients

Primary Purpose

Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Trimetazidine Dihydrochloride
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Trimetazidine, Diastolic dysfunction, diabetes mellitus

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ainshams university hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline Left ventricular functions at 3 months
assessed using echocardiographic and tissue doppler evaluation

Secondary Outcome Measures

Change from baseline Tumor necrosis factor alpha at 3 months
assessed using ELISA technique
Change from baseline Transforming growth factor beta 1 at 3 months
assessed using ELISA technique

Full Information

First Posted
September 21, 2022
Last Updated
September 26, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05556005
Brief Title
Efficacy of Trimetazidine in Diabetic Patients
Official Title
Effect Of Trimetazidine On Left Ventricular Functions and Inflammatory Markers of Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies
Keywords
Trimetazidine, Diastolic dysfunction, diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Patients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Patients will receive Placebo tablet twice daily in addition to their standard treatment for three months.
Intervention Type
Drug
Intervention Name(s)
Trimetazidine Dihydrochloride
Other Intervention Name(s)
Vasteral mr
Intervention Description
Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Starch tablets used twice daily
Primary Outcome Measure Information:
Title
Change from baseline Left ventricular functions at 3 months
Description
assessed using echocardiographic and tissue doppler evaluation
Time Frame
at baseline and after three months of intervention
Secondary Outcome Measure Information:
Title
Change from baseline Tumor necrosis factor alpha at 3 months
Description
assessed using ELISA technique
Time Frame
at baseline and after three months of intervention
Title
Change from baseline Transforming growth factor beta 1 at 3 months
Description
assessed using ELISA technique
Time Frame
at baseline and after three months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
heba I serag, Master
Phone
01008344689
Ext
002
Email
hebaibrahim92@pharm.asu.edu.eg
Facility Information:
Facility Name
Ainshams university hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lamia El wakeel, Professor
Email
Lamia.elwakeel@pharma.asu.edu.eg

12. IPD Sharing Statement

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Efficacy of Trimetazidine in Diabetic Patients

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