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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Captopril
* Drug: L-carnitine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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