Efficacy of Trimetazidine in Diabetic Patients

Last updated: September 26, 2022
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT05556005
RHDIRB2020110301
  • Ages 40-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age from 40-75 years
  2. Patients with echocardiographic evidence of grade I or II diastolic dysfunction withLVEF ≥50%

Exclusion

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 (creatinineclearance < 30 ml/min)
  6. Patients with other significant comorbidities such as malignancy, significantpsychiatric illness, autoimmune diseases.
  7. Patients with Parkinson's disease or motor disorders
  8. Pregnancy and breast feeding

Study Design

Total Participants: 60
Study Start date:
September 18, 2022
Estimated Completion Date:
September 30, 2023

Connect with a study center

  • Ainshams university hospitals

    Cairo,
    Egypt

    Active - Recruiting

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