NCT07455994 Dysautonomia in Children With Type 1 Diabetes
| NCT ID | NCT07455994 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Dysautonomia in Children With Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-22 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07455994 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 17 Years, studying Dysautonomia in Children With Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07455994 currently recruiting?
Yes, NCT07455994 is actively recruiting participants. Contact the research team at hugues.patural@chu-st-etienne.fr for enrollment information.
Where is the NCT07455994 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT07455994 clinical trial?
NCT07455994 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The trial plans to enroll 100 participants.
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