跳至主要内容
临床试验/NCT07455994
NCT07455994招募中不适用

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

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月22日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
HF ECG index value

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Year 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Diabetic subjects

Experimental

50 pediatric diabetic subjects with at least 5 years of type 1 diabetes).

干预措施: Neurocoach® and Sudoscan® (Diagnostic Test)

healthy group

Active Comparator

50 healthy subjects matched for age and sex

干预措施: Neurocoach® and Sudoscan® (Diagnostic Test)

结局指标

主要结局

HF ECG index value

时间窗: During 24 hours

HF index value (ms2/Hz) of high-frequency heart rate variability in the frequency domain

次要结局

  • Sympathetic and parasympathetic indices of heart rate variability(During 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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