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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2025-A02293-46 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic subjects | Experimental | 50 pediatric diabetic subjects with at least 5 years of type 1 diabetes). |
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| healthy group | Active Comparator | 50 healthy subjects matched for age and sex |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurocoach® and Sudoscan® | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HF ECG index value | HF index value (ms2/Hz) of high-frequency heart rate variability in the frequency domain | During 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sympathetic and parasympathetic indices of heart rate variability | Secondary endpoints: Sympathetic and parasympathetic indices of heart rate variability in the linear frequency domains (Ptot, VLF, LF, LF/HF ratio), time domains (SDNN, pNN30, pNN50, rMSSD), and nonlinear domains (Approximate entropy, SD1, SD2, chaos). Quantifying the Mean ESC value (µS) of the hands and feet. | During 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugues PATURAL, MD PhD | Contact | (0)4 77 82 82 42 | +33 | hugues.patural@chu-st-etienne.fr |
| Meryem BRITAL, CDP | Contact | (0)4 77 42 06 83 | +33 | meryem.brital@chu-st-etienne.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D001342 | Autonomic Nervous System Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| D009422 | Nervous System Diseases |