Dysautonomia in Children With Type 1 Diabetes

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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  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.

Первичные конечные точки

• HF ECG index value [Срок оценки: During 24 hours]

Вторичные конечные точки (1)

• Sympathetic and parasympathetic indices of heart rate variability [Срок оценки: During 24 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Chu de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT07455994 · 25CH195 · ANSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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