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

NCT07613372 | Active Not Recruiting DMC

• 1 other identifier: 36265MD41032/2/26
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Autonomic Neuropathy; Diabete Type 1; Pediatrics

Outcome Measures

Primary Outcomes (1)

• evaluate the prevalence of cardiac autonomic neuropathy in children with Type 1 DM and correlation with duration of DM and glycemic control.

  up to 24 months

Study Arms (3)

Case Group 1-A

EXPERIMENTAL

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

Case Group 1-B

EXPERIMENTAL

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

Control Group (Group 2)

EXPERIMENTAL

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

Interventions

Holter DEVICE

Baseline Electrocardiogram (ECG) Cardiac Autonomic Reflex Tests (CARTs)

Case Group 1-A; Case Group 1-B; Control Group (Group 2)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: collaborator
• Marwa Abouelela Abd Elsalam: lead

Study Sites (1)

Tanta university

Al Gharbī Bahjūrah, Egypt

Location

MeSH Terms

Interventions

Electrocardiography, Ambulatory

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of paediatrics faculty of medicine Tanta university

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the end of the study for one year

Locations

EG (1)