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Dysautonomia in Children With Type 1 Diabetes: "DysDiab" Single-center Study
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.
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.
Age
1 - 17 years
Sex
ALL
Healthy Volunteers
Yes
Chu de Saint-Etienne
Saint-Etienne, France
Start Date
December 22, 2025
Primary Completion Date
December 1, 2026
Completion Date
May 1, 2027
Last Updated
March 6, 2026
100
ESTIMATED participants
Neurocoach® and Sudoscan®
DIAGNOSTIC_TEST
Lead Sponsor
Centre Hospitalier Universitaire de Saint Etienne
NCT00090662
NCT07310264
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06342713