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NCT Number: NCT07455994

Dysautonomia in Children With Type 1 Diabetes

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.

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Key information

Conditions

Dysautonomia in Children With Type 1 Diabetes Autonomic Nervous System Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Volunteer Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Hugues PATURAL, MD PhD

CONTACT

[email protected]

(0)4 77 82 85 42 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Children with a diagnosis of diabetes of less than 5 years' duration at the time of inclusion.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. HF ECG index value

    Time frame: During 24 hours

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

Secondary outcomes

  1. Sympathetic and parasympathetic indices of heart rate variability

    Time frame: During 24 hours

    Secondary endpoints: Sympathetic and parasympathetic indices of heart rate variability in the linear frequency domains (Ptot, VLF, LF, LF/HF ratio), time domains (SDNN, pNN30, pNN50, rMSSD), and nonlinear domains (Approximate entropy, SD1, SD2, chaos).

    Quantifying the Mean ESC value (µS) of the hands and feet.

Study contacts

Contact information is provided by the study sponsor or research team.

Hugues PATURAL, MD PhD

CONTACT

[email protected]

(0)4 77 82 82 42 ext. +33

Meryem BRITAL, CDP

CONTACT

[email protected]

(0)4 77 42 06 83 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Dysautonomia in Children With Type 1 Diabetes: "DysDiab" Single-center Study

Acronym: DYSDIAB

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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