Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT03660293
- Lead Sponsor
- Tanta University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Children and adolescent suffering from type 1 Diabetes Mellitus, for at least 3 years from the onset of the disease.
- Children with Congenital Heart Diseases.
- Children with acquired cardiac diseases.
- Children with other systemic diseases.
- Symptomatic diabetic cardiomyopathy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description diabetic-Atorvastatin Atorvastatin 25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day) diabetic-Captopril Captopril 25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day) diabetic-L-Carnitine L-carnitine 25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day)
- Primary Outcome Measures
Name Time Method The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents. 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 Outcome Measures
Name Time Method The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children. first day Serum Cardiac troponin I by Enzyme Linked ImmunoSorbant Assay
The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction first day Echocardiography
Identification of risk factors for developing diabetic cardiac insult. first day
Trial Locations
- Locations (1)
Faculty of Medicine- Tanta University
🇪🇬Tanta, Gharbia, Egypt