NCT03660293

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 17, 2019

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

July 11, 2018

Last Update Submit

June 14, 2019

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    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 Outcomes (3)

  • The role of Troponin I levels as a cardiac marker for detection of asymptomatic cardiovascular insult in diabetic children.

    first day

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

    first day

  • Identification of risk factors for developing diabetic cardiac insult.

    first day

Study Arms (5)

diabetic- no cardioprotectives

NO INTERVENTION

25 child with type 1 diabetes mellitus will not receive any cardio protective drug

diabetic-Atorvastatin

EXPERIMENTAL

25 child with type 1 diabetes mellitus will receive Statin (2 mg/kg/day)

Drug: Atorvastatin

diabetic-Captopril

EXPERIMENTAL

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

Drug: Captopril

diabetic-L-Carnitine

EXPERIMENTAL

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

Drug: L-carnitine

Controls

NO INTERVENTION

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

Interventions

AtorvastatinDRUG

cardio-protective agents

diabetic-Atorvastatin
CaptoprilDRUG

cardio-protective agents

diabetic-Captopril
L-carnitineDRUG

cardio-protective agents

diabetic-L-Carnitine

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, 0000, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 33536102DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

AtorvastatinCaptoprilCarnitine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Professor of Pediatrics

Study Record Dates

First Submitted

July 11, 2018

First Posted

September 6, 2018

Study Start

April 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 17, 2019

Record last verified: 2018-09

Locations

EG(1)