Dysautonomia in Children With Type 1 Diabetes

NCT07455994 | Recruiting

• 2 other identifiers: 25CH195ANSM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Some physiological factors, such as physical activity, or pathological factors, such as sepsis or diabetes, are known to modulate the overall autonomic activity and the individual's intrinsic capacity to regulate their sympathetic and parasympathetic balance. These conditions can alter the physiological autonomic balance, sometimes with positive consequences on the FC-breathing control and blood pressure adjustment, depending on the individual's position and the status of blood volume, but sometimes with deleterious effects, such as poor regulation of sinus cardiac activity and respiration rate. Cardiovascular autonomic neuropathy is a major complication of type 1 diabetes. Several studies have described autonomic dysfunction in patients with type 1 diabetes, but these data are derived from cohorts of adults and adolescents or short ECG recordings at rest. Moreover, there are often confounding factors such as sedentary/physical activity, overweight, exposure to post-pubertal hormonal peaks, toxic drugs, or cardiac therapy. These factors don't greatly influence children's autonomic physiological maturation, whereas diabetes can sometimes exist for several years. In this population, the search for cardiac dysautonomia is entirely appropriate.

Conditions

Dysautonomia in Children With Type 1 Diabetes; Healthy Volunteer

Keywords

diabetes; dysautonomia

Outcome Measures

Primary Outcomes (1)

• HF ECG index value

  HF index value (ms2/Hz) of high-frequency heart rate variability in the frequency domain

  During 24 hours

Secondary Outcomes (1)

• Sympathetic and parasympathetic indices of heart rate variability

  During 24 hours

Study Arms (2)

Diabetic subjects

EXPERIMENTAL

50 pediatric diabetic subjects with at least 5 years of type 1 diabetes).

Diagnostic Test: Neurocoach® and Sudoscan®

healthy group

ACTIVE COMPARATOR

50 healthy subjects matched for age and sex

Diagnostic Test: Neurocoach® and Sudoscan®

Interventions

Neurocoach® and Sudoscan® DIAGNOSTIC_TEST

The objective of this study is to evaluate the indices of heart rate variability (from a 24-hour Holter and a cutaneous conductance) in children with type 1 diabetes compared with healthy controls matched to sex and age, and to determine whether the occurrence of cardiac dysautonomia is correlated with the duration of diabetes progression.

Diabetic subjects; healthy group

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parents affiliates or entitled to the French Social Security Fund
• Children\<18 years with type 1 diabetes followed in consultation at the University Hospital of Saint-Etienne
• Children under 18 years of age, matched for age (±6 months) and sex, without diabetes or dysautonomia (control group), who have not undergone anesthesia within the 2 months preceding the recording and are not receiving any cardiac (beta-blocker) or antiarrhythmic treatment.

You may not qualify if:

• Children with diseases that affect the central nervous system or brainstem
• Children suffering from a serious pathology of the cardiorespiratory system or during cardiac treatment (cardiopathies, rhythmic disorders)
• Foreign parents or children who don't speak French.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Nervous System Diseases

Central Study Contacts

Hugues PATURAL, MD PhD

CONTACT

(0)4 77 82 82 42; hugues.patural@chu-st-etienne.fr

Meryem BRITAL, CDP

CONTACT

(0)4 77 42 06 83; meryem.brital@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (1)