Dysautonomia in Children With Type 1 Diabetes

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Diagnostic test Neurocoach® and Sudoscan®
  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 outcome measures

• HF ECG index value [Time frame: During 24 hours]

Secondary outcome measures (1)

• Sympathetic and parasympathetic indices of heart rate variability [Time frame: During 24 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 1 center

• Chu de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07455994 · 25CH195 · ANSM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗