RecruitingNot ApplicableNCT07455994

Dysautonomia in Children With Type 1 Diabetes

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


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

100 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether children with type 1 diabetes show signs of dysautonomia—a condition where the part of the nervous system that automatically controls heart rate, blood pressure, and other body functions does not work properly. Researchers will compare children with diabetes to healthy children of similar age to detect early nerve changes. **You may be eligible if...** - Your child has type 1 diabetes and is under 18 years old, followed at the University Hospital of Saint-Etienne in France - Your child has had diabetes for at least 5 years - (For the control group) Your child is under 18, does not have diabetes, and is matched to a diabetic child by age and sex **You may NOT be eligible if...** - Your child has had type 1 diabetes for less than 5 years - Your child has a condition affecting the brain or brainstem - Your child has a serious heart or breathing problem, or is taking beta-blockers or anti-arrhythmic medications - Your family does not speak French Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTNeurocoach® 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.


Locations(1)

Chu de Saint-Etienne

Saint-Etienne, France

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NCT07455994


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