Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-24 @ 9:00 AM
Study NCT ID:
NCT02538120
Status:
COMPLETED
Last Update Posted:
2016-02-12
First Post:
2015-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-11', 'studyFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2015-08-28', 'lastUpdatePostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurovascular microcirculatory response', 'timeFrame': 'one day', 'description': 'Neurovascular response will be assessed by laser speckle contrast imaging using various microvascular tests such as deionized water iontophoresis, local heating test. Results will be explained in Laser Speckle Perfusion Units (LSPU)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 1']}, 'referencesModule': {'references': [{'pmid': '28287157', 'type': 'DERIVED', 'citation': 'Marche P, Dubois S, Abraham P, Parot-Schinkel E, Gascoin L, Humeau-Heurtier A, Ducluzeau PH, Mahe G. Neurovascular microcirculatory vasodilation mediated by C-fibers and Transient receptor potential vanilloid-type-1 channels (TRPV 1) is impaired in type 1 diabetes. Sci Rep. 2017 Mar 13;7:44322. doi: 10.1038/srep44322.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to see whether or not the diabetes 1 patients have a neurovascular microcirculatory dysfunction using various microvascular tests which have been previously validated.\n\nMicrovascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in Laser Speckle Perfusion Units (LSPU).', 'detailedDescription': 'The investigators will compare microvascular responses between diabetes type 1 patients with matched control-subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes type 1 patients\n* Matched control-subjects\n\nExclusion Criteria:\n\n* Patients or subjects with anti-inflammatory drugs'}, 'identificationModule': {'nctId': 'NCT02538120', 'acronym': 'NEURODIAB1', 'briefTitle': 'Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1', 'orgStudyIdInfo': {'id': '2012-A010008-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetes type 1 patients', 'description': 'The intervention will be : Microvascular assessment with laser speckle contrast imaging', 'interventionNames': ['Other: Microvascular assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Matched control-subjects', 'description': 'The intervention will be : Microvascular assessment with laser speckle contrast imaging', 'interventionNames': ['Other: Microvascular assessment']}], 'interventions': [{'name': 'Microvascular assessment', 'type': 'OTHER', 'description': 'Microvascular assessment', 'armGroupLabels': ['Diabetes type 1 patients', 'Matched control-subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Severine Dubois, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}