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

June 14, 2019 updated by: Rasha Mohamed Gamal, Tanta University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 0000
        • Faculty of Medicine- Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before and after 4 months of receiving cardio-protective agents
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.
before and after 4 months of receiving cardio-protective agents

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
first day
The role of recent echocardiographic parameters for early detection of silent myocardial dysfunction
Time Frame: first day
Echocardiography
first day
Identification of risk factors for developing diabetic cardiac insult.
Time Frame: first day
first day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 17, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31499/04/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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