Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:51 AM
Study NCT ID:
NCT07455994
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dysautonomia in Children With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HF ECG index value', 'timeFrame': 'During 24 hours', 'description': 'HF index value (ms2/Hz) of high-frequency heart rate variability in the frequency domain'}], 'secondaryOutcomes': [{'measure': 'Sympathetic and parasympathetic indices of heart rate variability', 'timeFrame': 'During 24 hours', 'description': '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).\n\nQuantifying the Mean ESC value (µS) of the hands and feet.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'dysautonomia'], 'conditions': ['Dysautonomia in Children With Type 1 Diabetes', 'Healthy Volunteer']}, 'descriptionModule': {'briefSummary': "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.\n\nCardiovascular 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.\n\nThese 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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parents affiliates or entitled to the French Social Security Fund\n* Children\\<18 years with type 1 diabetes followed in consultation at the University Hospital of Saint-Etienne\n* 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.\n\nExclusion Criteria:\n\n* Children with a diagnosis of diabetes of less than 5 years' duration at the time of inclusion.\n* Children with diseases that affect the central nervous system or brainstem\n* Children suffering from a serious pathology of the cardiorespiratory system or during cardiac treatment (cardiopathies, rhythmic disorders)\n* Foreign parents or children who don't speak French."}, 'identificationModule': {'nctId': 'NCT07455994', 'acronym': 'DYSDIAB', 'briefTitle': 'Dysautonomia in Children With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Dysautonomia in Children With Type 1 Diabetes: "DysDiab" Single-center Study', 'orgStudyIdInfo': {'id': '25CH195'}, 'secondaryIdInfos': [{'id': 'ANSM', 'type': 'OTHER', 'domain': '2025-A02293-46'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetic subjects', 'description': '50 pediatric diabetic subjects with at least 5 years of type 1 diabetes).', 'interventionNames': ['Diagnostic Test: Neurocoach® and Sudoscan®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy group', 'description': '50 healthy subjects matched for age and sex', 'interventionNames': ['Diagnostic Test: Neurocoach® and Sudoscan®']}], 'interventions': [{'name': 'Neurocoach® and Sudoscan®', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Diabetic subjects', 'healthy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hugues PATURAL, MD PhD', 'role': 'CONTACT', 'email': 'hugues.patural@chu-st-etienne.fr', 'phone': '(0)4 77 82 85 42', 'phoneExt': '+33'}], 'facility': 'Chu de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Hugues PATURAL, MD PhD', 'role': 'CONTACT', 'email': 'hugues.patural@chu-st-etienne.fr', 'phone': '(0)4 77 82 82 42', 'phoneExt': '+33'}, {'name': 'Meryem BRITAL, CDP', 'role': 'CONTACT', 'email': 'meryem.brital@chu-st-etienne.fr', 'phone': '(0)4 77 42 06 83', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}