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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660293
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Rasha Mohamed Gamal, Tanta University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Atorvastatin Drug: Captopril Drug: L-carnitine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardio-protective Drugs
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Captopril

Arms and Interventions
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Arm Intervention/treatment
No Intervention: diabetic- no cardioprotectives
25 child with type 1 diabetes mellitus will not receive any cardio protective drug
Experimental: diabetic-Atorvastatin
25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day)
 Drug: Atorvastatin
cardio-protective agents
Experimental: diabetic-Captopril
25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day)
 Drug: Captopril
cardio-protective agents
Experimental: diabetic-L-Carnitine
25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day)
 Drug: L-carnitine
cardio-protective agents
No Intervention: Controls
50 healthy children, of matched age and sex, with no symptoms of cardiac diseases


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660293


Locations
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Egypt
Faculty of Medicine- Tanta University
Tanta, Gharbia, Egypt, 0000
Sponsors and Collaborators
Tanta University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rasha Mohamed Gamal, Ass. Professor of Pediatrics, Tanta University
ClinicalTrials.gov Identifier: NCT03660293    
Other Study ID Numbers: 31499/04/17
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Captopril
Atorvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents