Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT04226820
Status:
UNKNOWN
Last Update Posted:
2023-11-30
First Post:
2020-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D028361', 'term': 'Mitochondrial 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'There is no masking because the participant knows his diagnosis. Besides, the investigator checks the blood sugar at different times during the examinations, so also the investigator is not blinded. In this study, blinding would have no additional value.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants are divided into 3 groups based on their diagnosis: diabetes mellitus type 1, diabetes mellitus type 2, and healthy persons. Each participant (independent of group) will have the same examinations. There is no retesting of the same participant in other conditions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow Mediated Dilatation (FMD)-test', 'timeFrame': '20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)', 'description': 'flow mediated dilatation test'}, {'measure': 'Near-infrared spectroscopy during exercise', 'timeFrame': '30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)', 'description': 'analysis of changes in oxygenated blood during exercise'}, {'measure': 'exercise test wilt hand held dynamometer', 'timeFrame': '30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)', 'description': 'analysis of strength and exercise capacity'}], 'secondaryOutcomes': [{'measure': 'Blood pressure analysis', 'timeFrame': '20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)', 'description': 'measurement of basal blood pressure (systolic and diastolic)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'muscular oxygenation', 'vascular function'], 'conditions': ['Diabetes Mellitus', 'Vascular Complications', 'Mitochondrial Diseases']}, 'descriptionModule': {'briefSummary': 'Oxygen is required for an optimal muscle function. In patients with diabetes mellitus, hyperglycemia can cause vascular complications. The endothelium (inter layer of the blood vessels) can be damaged leading to a reduced oxygen flow towards the muscle cells. Besides, it is possible that mitochondrial dysfunction is occuring leading to reduced extraction of oxygen.\n\nBoth conditions will lead to a reduced flow of oxygen towards the muscle and this can have impact on the production of energy necessary for optimal functioning.\n\nIn this study, the investigators will examine the functionality of the blood vessels (1) and the uptake of oxygen into the muscles (2) in patients with diabetes mellitus type 1 and type 2 (with and without vascular complications) compared to healthy persons.', 'detailedDescription': 'The investigators plan to recruit in total 125 participants who will be divided into 3 main groups: (I) diabetes mellitus type 1 (with (a) or without (b) vascular complications), (II) diabetes mellitus type 2 (with (a) or without (b) vascular complications), and (III) healthy persons. Diabetes mellitus will be defined by the guidelines of the American Diabetes Association (ADA).\n\nThe examinations for this study consist of a blood pressure assessment, Flow Mediated Dilatation (FMD)-measurement, and a handgrip exercise test. The protocol will take approximately 2 hours.\n\nThe investigator who performs the FMD-test followed a course and passed thorough evaluation.\n\nThe blood pressure assessment will be continuously for 20 minutes to avoid large bias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women\n* age 18-85 years old\n* diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants\n\nExclusion Criteria:\n\n* other types of diabetes mellitus than type 1 or type 2\n* alcohol abuse\n* active cancer\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04226820', 'acronym': 'PREMOD', 'briefTitle': 'Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'B670201940995'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'participant', 'description': 'Participants are divided into 3 groups based on their diagnosis: diabetes mellitus type 1, diabetes mellitus type 2, and healthy persons. Each participant (independent of group) will have the same examinations. There is no retesting of the same participant in other conditions.', 'interventionNames': ['Other: examination: blood pressure assessment', 'Other: examination: Flow Mediated Dilatation (FMD)-test', 'Other: examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring', 'Other: examination: measurement of glucose by a finger prick']}], 'interventions': [{'name': 'examination: blood pressure assessment', 'type': 'OTHER', 'description': 'blood pressure measurement for 30 minutes, dominant side', 'armGroupLabels': ['participant']}, {'name': 'examination: Flow Mediated Dilatation (FMD)-test', 'type': 'OTHER', 'description': 'Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality', 'armGroupLabels': ['participant']}, {'name': 'examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring', 'type': 'OTHER', 'description': 'participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation', 'armGroupLabels': ['participant']}, {'name': 'examination: measurement of glucose by a finger prick', 'type': 'OTHER', 'description': 'follow-up of blood sugar (glucose) during examinations by a finger prick', 'armGroupLabels': ['participant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Anouk Tanghe, PhD', 'role': 'CONTACT', 'email': 'anouk.tanghe@ugent.be', 'phone': '+32 9 332 36 27'}], 'facility': 'University Gent, Rehabilitation Sciences', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Anouk Tanghe, PhD', 'role': 'CONTACT', 'email': 'anouk.tanghe@ugent.be', 'phone': '+32 09 332 36 27'}, {'name': 'Patrick Calders, Prof. dr.', 'role': 'CONTACT', 'email': 'patrick.calders@ugent.be', 'phone': '+32 09 332 69 15'}], 'overallOfficials': [{'name': 'Samyah Shadid, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Ghent and University of Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}