Actively Recruiting

Phase Not Applicable
Age: 1Year - 17Years
All Genders
Healthy Volunteers
NCT07455994

Dysautonomia in Children With Type 1 Diabetes

Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-03-06

100

Participants Needed

1

Research Sites

70 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Dysautonomia in Children With Type 1 Diabetes

Who Can Participate

Age: 1Year - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parents affiliates or entitled to the French Social Security Fund
  • Children under 18 years with type 1 diabetes followed at the University Hospital of Saint-Etienne
  • Healthy children under 18 years matched for age (±6 months) and sex, without diabetes or dysautonomia, no anesthesia within 2 months before recording, and not on beta-blocker or antiarrhythmic treatment
Not Eligible

You will not qualify if you...

  • Children with diabetes diagnosis less than 5 years prior to inclusion
  • Children with diseases affecting the central nervous system or brainstem
  • Children with serious cardiorespiratory diseases or on cardiac treatment (cardiopathies, rhythmic disorders)
  • Children or parents who are foreign or do not speak French

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chu de Saint-Etienne

Saint-Etienne, France, 42055

Actively Recruiting

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Research Team

H

Hugues PATURAL, MD PhD

CONTACT

M

Meryem BRITAL, CDP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Dysautonomia in Children With Type 1 Diabetes | DecenTrialz