Evaluation of Cardiac Autonomic Neuropathy in Children and Adolescents With Type 1 Diabetes Mellitus

May 23, 2026 updated by: Marwa Abouelela Abd Elsalam
study is to evaluate the prevalence of cardiac autonomic neuropathy in children with Type 1 DM and correlation with duration of DM and glycemic control.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

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
      • Al Gharbī Bahjūrah, Egypt
        • 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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age ≤18 years old Both males and females will be included. Patients diagnosed with type 1 DM for a duration ≥ 5 y. Both well controlled and poorly controlled patients will be included.

Exclusion Criteria:

Patients with diabetes other than Type 1 DM. Coexisting medical conditions such as thyroid disorders, celiac disease, epilepsy, or chronic pulmonary or hepatic disease.

Known cardiac conditions, including congenital heart disease, cardiomyopathy, conduction disorders, or previous cardiac surgery.

Acute illness at the time of evaluation or history of diabetic ketoacidosis within the preceding 3 months.

Use of medications affecting heart rate or rhythm, including beta-blockers, theophylline, or levothyroxine

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Case Group 1-A
evaluation of autonomic cardiac neuropathy using 24 hrs rhythm Holter and Cardiac Autonomic Reflex Tests (CARTs) in children and adolescent with type 1 DM for 5 - 10 years
Device: Holter
Baseline Electrocardiogram (ECG) Cardiac Autonomic Reflex Tests (CARTs)
Experimental: Case Group 1-B
evaluation of autonomic cardiac neuropathy using 24 hrs rhythm Holter and Cardiac Autonomic Reflex Tests (CARTs) in children and adolescent with type 1 DM more than 10 years
Device: Holter
Baseline Electrocardiogram (ECG) Cardiac Autonomic Reflex Tests (CARTs)
Experimental: Control Group (Group 2)
evaluation of autonomic cardiac neuropathy using 24 hrs rhythm Holter and Cardiac Autonomic Reflex Tests (CARTs) in children and adolescent in healthy children
Device: Holter
Baseline Electrocardiogram (ECG) Cardiac Autonomic Reflex Tests (CARTs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluate the prevalence of cardiac autonomic neuropathy in children with Type 1 DM and correlation with duration of DM and glycemic control.
Time Frame: up to 24 months
up to 24 months

Collaborators and Investigators

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

Sponsor

Marwa Abouelela Abd Elsalam

Collaborators

Tanta University

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)

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 23, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36265MD41032/2/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the data will be available upon a reasonable request from the corresponding author after the end of the study for one year

IPD Sharing Time Frame

after the end of the study for one year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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