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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

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 1

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

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

NCT ID

NCT03660293

First Posted

July 11, 2018

Last Updated

June 14, 2019

Sponsor

Tanta University

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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