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NCT07455994Recruiting

Dysautonomia in Children With Type 1 Diabetes

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

Source: ClinicalTrials.gov · Last updated 6 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
3 Mar 2026
Start date
22 Dec 2025
Primary completion date
31 Dec 2026
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
NCT number
NCT07455994

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 22 Dec 2025 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)

Other

  • Foreign parents or children who don't speak French.

Who the study is looking for

  • 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.

Age in the registry: 1 year to 17 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu de Saint Etienne
Coordinator of this site? Confirm its status
Saint-EtienneFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.