Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Atorvastatin
Captopril
L-carnitine
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 1
Eligibility 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.
Sites / Locations
- Faculty of Medicine- Tanta University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
Experimental
Experimental
Experimental
No Intervention
Arm Label
diabetic- no cardioprotectives
diabetic-Atorvastatin
diabetic-Captopril
diabetic-L-Carnitine
Controls
Arm Description
25 child with type 1 diabetes mellitus will not receive any cardio protective drug
25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day)
25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day)
25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day)
50 healthy children, of matched age and sex, with no symptoms of cardiac diseases
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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
The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction
Echocardiography
Identification of risk factors for developing diabetic cardiac insult.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03660293
Brief Title
Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs
Official Title
Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardio-protective Drugs
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diabetic- no cardioprotectives
Arm Type
No Intervention
Arm Description
25 child with type 1 diabetes mellitus will not receive any cardio protective drug
Arm Title
diabetic-Atorvastatin
Arm Type
Experimental
Arm Description
25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day)
Arm Title
diabetic-Captopril
Arm Type
Experimental
Arm Description
25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day)
Arm Title
diabetic-L-Carnitine
Arm Type
Experimental
Arm Description
25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day)
Arm Title
Controls
Arm Type
No Intervention
Arm Description
50 healthy children, of matched age and sex, with no symptoms of cardiac diseases
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
cardio-protective agents
Intervention Type
Drug
Intervention Name(s)
Captopril
Intervention Description
cardio-protective agents
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Intervention Description
cardio-protective agents
Primary Outcome Measure Information:
Title
The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.
Description
Corrected QT interval(QTc) and QT dispersion in ElectroCardioGram
Time Frame
before and after 4 months of receiving cardio-protective agents
Title
The cardiac changes induced by Simvastatin, captopril and L-Carnitine in type 1 diabetic children and adolescents.
Description
Left Ventricular End Systolic Volume (ml). Left Ventricular End Diastolic Volume (ml). Ejection Fraction (EF %) and left ventricular strain using echocardiography.
Time Frame
before and after 4 months of receiving cardio-protective agents
Secondary Outcome Measure Information:
Title
The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.
Description
Serum Cardiac troponin I by Enzyme Linked ImmunoSorbant Assay
Time Frame
first day
Title
The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction
Description
Echocardiography
Time Frame
first day
Title
Identification of risk factors for developing diabetic cardiac insult.
Time Frame
first day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Faculty of Medicine- Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
0000
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
33536102
Citation
Badreldeen A, El Razaky O, Erfan A, El-Bendary A, El Amrousy D. Comparative study of the efficacy of captopril, simvastatin, and L-carnitine as cardioprotective drugs in children with type 1 diabetes mellitus: a randomised controlled trial. Cardiol Young. 2021 Aug;31(8):1315-1322. doi: 10.1017/S1047951121000226. Epub 2021 Feb 4.
Results Reference
derived
Learn more about this trial
Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs
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