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CompletedNCT03660293Updated Jun 17, 2019

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

An interventional study of Atorvastatin and Captopril in Diabetes Mellitus, Type 1, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-17.

Sponsored by Tanta University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Apr 2017, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 150 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Children and adolescent suffering from type 1 Diabetes Mellitus, for at least 3 years from the onset of the disease.

Exclusion criteria

Exclusion Criteria:

  • Children with Congenital Heart Diseases.
  • Children with acquired cardiac diseases.
  • Children with other systemic diseases.
  • Symptomatic diabetic cardiomyopathy.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • 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

  • Experimental
    diabetic-Captopril

    25 child with type 1 diabetes mellitus will receive Captopril (0.2 mg/kg/day)

    Drug: Captopril

  • Experimental
    diabetic-L-Carnitine

    25 child with type 1 diabetes mellitus will receive L-carnitine (50 mg/kg/day)

    Drug: L-carnitine

  • No intervention
    Controls

    50 healthy children, of matched age and sex, with no symptoms of cardiac diseases

Interventions

  • DrugAtorvastatin

    cardio-protective agents

  • DrugCaptopril

    cardio-protective agents

  • DrugL-carnitine

    cardio-protective agents

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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.

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

Secondary outcomes

  1. 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

    Time frame: first day

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

    Echocardiography

    Time frame: first day

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

    Time frame: first day

07

Study locations

1 site
  • Faculty of Medicine- Tanta University
    Tanta, Gharbia 0000, Egypt
08

References and documents

Publications

  • 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. PubMed 33536102 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03660293
Lead sponsor
Tanta University
Responsible party
Rasha Mohamed Gamal (Ass. Professor of Pediatrics, Tanta University) — Principal investigator
First posted
Sep 6, 2018
Start date
Apr 1, 2017
Primary completion
Jun 1, 2019
Completion
Jun 1, 2019
Last update
Jun 17, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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