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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03660293
Enrollment
150
Registered
2018-09-06
Start date
2017-04-01
Completion date
2019-06-01
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

DRUGAtorvastatin

cardio-protective agents

DRUGCaptopril

cardio-protective agents

DRUGL-carnitine

cardio-protective agents

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
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 agentsCorrected QT interval(QTc) and QT dispersion in ElectroCardioGram

Secondary

MeasureTime frameDescription
The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.first daySerum Cardiac troponin I by Enzyme Linked ImmunoSorbant Assay
The role of recent echocardiographic parameters for early detection of silent myocardial dysfunctionfirst dayEchocardiography
Identification of risk factors for developing diabetic cardiac insult.first day—

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026