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NCT03660293 Clinical Trial

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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03660293
Other study ID # 31499/04/17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date June 1, 2019

Study information
Verified date September 2018
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 18 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Faculty of Medicine- Tanta University Tanta Gharbia

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction Echocardiography first day
Secondary Identification of risk factors for developing diabetic cardiac insult. first day
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