Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs

Overview

Diabetic cardiomyopathy (DCM) is a distinct clinical entity of diabetic heart muscle that describes diabetes associated changes in the structure and function of the myocardium in the absence of coronary artery disease, hypertension, and valvular disease. Oxidative stress plays a critical role in DCM development. DCM can be diagnosed using the novel methods of echocardiography (tissue Doppler imaging, Speckling tracking techniques and more recent real time 4D echocardiography). There is a possible cardioprotective effect of statins, Captopril and L-Carnitine in type 1 diabetic children and adolescents.

Full Title of Study: “Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardio-protective Drugs”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 1, 2019

Interventions

  • Drug: Atorvastatin
    • cardio-protective agents
  • Drug: Captopril
    • cardio-protective agents
  • Drug: L-carnitine
    • cardio-protective agents

Arms, Groups and Cohorts

  • No Intervention: diabetic- no cardioprotectives
    • 25 child with type 1 diabetes mellitus will not receive any cardio protective drug
  • Experimental: diabetic-Atorvastatin
    • 25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day)
  • Experimental: diabetic-Captopril
    • 25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day)
  • Experimental: diabetic-L-Carnitine
    • 25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day)
  • No Intervention: Controls
    • 50 healthy children, of matched age and sex, with no symptoms of cardiac diseases

Clinical Trial Outcome Measures

Primary Measures

  • The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.
    • Time Frame: before and after 4 months of receiving cardio-protective agents
    • Corrected QT interval(QTc) and QT dispersion in ElectroCardioGram
  • The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.
    • Time Frame: before and after 4 months of receiving cardio-protective agents
    • Left Ventricular End Systolic Volume (ml). Left Ventricular End Diastolic Volume (ml). Ejection Fraction (EF %) and left ventricular strain using echocardiography.

Secondary Measures

  • The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.
    • Time Frame: first day
    • Serum Cardiac troponin I by Enzyme Linked ImmunoSorbant Assay
  • The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction
    • Time Frame: first day
    • Echocardiography
  • Identification of risk factors for developing diabetic cardiac insult.
    • Time Frame: first day

Participating in This Clinical Trial

Inclusion Criteria

  • Children and adolescent suffering from type 1 Diabetes Mellitus, for at least 3 years from the onset of the disease. Exclusion Criteria:

  • Children with Congenital Heart Diseases. – Children with acquired cardiac diseases. – Children with other systemic diseases. – Symptomatic diabetic cardiomyopathy.

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Tanta University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rasha Mohamed Gamal, Ass. Professor of Pediatrics – Tanta University

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