Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07613372
Enrollment
75
Registered
2026-05-29
Start date
2026-02-01
Completion date
2028-02-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Autonomic Neuropathy, Diabete Type 1, Pediatrics

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.

Interventions

DEVICEHolter

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

Sponsors

Marwa Abouelela Abd Elsalam
Lead SponsorOTHER
Tanta University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026