Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT03930004
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D058065', 'term': 'Diabetic Cardiomyopathies'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-06', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-04-25', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preclinical myocardial dysfunction', 'timeFrame': 'At patient inclusion.', 'description': 'Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value).'}, {'measure': 'Left ventricular diastolic dysfunction', 'timeFrame': 'At patient inclusion.', 'description': "Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when \\> 14)"}, {'measure': 'Left ventricular hypertrophy', 'timeFrame': 'At patient inclusion.', 'description': 'Incidence of patients with LV mass by linear measurements \\> 95 g/m2 if women and \\> 115 g/m2 if men.'}, {'measure': 'Left atrial dysfunction', 'timeFrame': 'At patient inclusion.', 'description': 'Incidence of patients with abnormal reservoir strain (normal range: 38%-41%), or abnormal conduit strain (normal range: 21%-25%), or abnormal contractile strain (normal range: 16%-19%).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Diabetic Cardiomyopathies', 'Autonomic Neuropathy, Diabetic']}, 'descriptionModule': {'briefSummary': 'Type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk of cardiovascular diseases. The development of cardiomyopathy in type 1 diabetes, independent of hypertension and coronary heart disease, is still controversial. A possible mechanism for diabetic cardiomyopathy is autonomic dysfunction. This study aims to evaluate cardiac function and structure, and to relate them with autonomic dysfunction in type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Selection of patients from a tertiary hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 1 diabetes mellitus\n\nExclusion Criteria:\n\n* hypertension\n* coronary artery disease\n* heart valve disease\n* ventricular dysfunction\n* radiotherapy or chemotherapy\n* alcoholism\n* limited acoustic window'}, 'identificationModule': {'nctId': 'NCT03930004', 'briefTitle': 'Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia de Santa Catarina'}, 'officialTitle': 'Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction', 'orgStudyIdInfo': {'id': 'HU-UFSC 2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 diabetic patients', 'description': 'Patients diagnosed with type 1 diabetes mellitus with criteria for cardiovascular autonomic neuropathy, asymptomatic, normotensive, with negative medical history of cardiovascular disease.\n\nTransthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of heart structure and function.'}, {'label': 'Control - Healthy subjects', 'description': 'Fifteen age- and sex-matched healthy control subjects, asymptomatic, normotensive, with negative medical history of cardiovascular disease.\n\nTransthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of heart structure and function.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '88036-500', 'city': 'Florianópolis', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'HU/UFSC', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}], 'overallOfficials': [{'name': 'Thais R Weber, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HU/UFSC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roberto Léo da Silva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Director', 'investigatorFullName': 'Roberto Léo da Silva', 'investigatorAffiliation': 'Instituto de Cardiologia de Santa Catarina'}}}}