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OpenTrials
Completed

NCT Number: NCT03660293

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, 0000, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

Drug

cardio-protective agents

captopril

Drug

cardio-protective agents

L-carnitine

Drug

cardio-protective agents

Primary outcomes

  1. The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.

    Time frame: before and after 4 months of receiving cardio-protective agents

    Corrected QT interval(QTc) and QT dispersion in ElectroCardioGram

  2. The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.

    Time frame: 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 outcomes

  1. The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.

    Time frame: first day

    Serum Cardiac troponin I by Enzyme Linked ImmunoSorbant Assay

  2. The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction

    Time frame: first day

    Echocardiography

  3. Identification of risk factors for developing diabetic cardiac insult.

    Time frame: first day

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2018
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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