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

Tanta University

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: L-carnitine; Drug: Captopril; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03660293

31499/04/17

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 5 patient groups

diabetic- no cardioprotectives

No Intervention group

Description:

25 child with type 1 diabetes mellitus will not receive any cardio protective drug

diabetic-Atorvastatin

Experimental group

Description:

25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day)

Treatment:

Drug: Atorvastatin

diabetic-Captopril

Experimental group

Description:

25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day)

Treatment:

Drug: Captopril

diabetic-L-Carnitine

Experimental group

Description:

25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day)

Treatment:

Drug: L-carnitine

Controls

No Intervention group

Description:

50 healthy children, of matched age and sex, with no symptoms of cardiac diseases