Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardio-protective Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
diabetic-Atorvastatin
25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day)
Intervention: Atorvastatin (Drug)
diabetic-Captopril
25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day)
Intervention: Captopril (Drug)
diabetic-L-Carnitine
25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day)
Intervention: L-carnitine (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.(first day)
- The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction(first day)
- Identification of risk factors for developing diabetic cardiac insult.(first day)
Investigators
Rasha Mohamed Gamal
Ass. Professor of Pediatrics
Tanta University