Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-04-13 @ 8:42 PM
Study NCT ID:
NCT00553995
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2007-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C014182', 'term': 'salicylsalicylic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2007-11-05', 'studyFirstSubmitQcDate': '2007-11-05', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reactive hyperemia in the femoral artery', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'Reactive hyperemia in the brachial artery', 'timeFrame': '5 days'}, {'measure': 'Oral glucose tolerance test', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Physical inactivity induces vascular dysfunction and glucose intolerance during five days of bed rest. This study will investigate the effects of salsalate on these responses. Subjects will be randomized to treatment with salsalate or placebo for four days prior to initiation of bed rest. Vascular function in the brachial artery will be determined by ultrasound prior to treatment and before and after the 5-day bed rest protocol. We hypothesize that treatment with salsalate will be associated with protection again the development of glucose intolerance and vascular dysfunction in this setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Pregnancy\n* History of Coronary Artery Disease\n* Diabetes Mellitus\n* Hypertension\n* Cigarette smoking\n* History or family history of deep vein thrombosis or pulmonary embolism\n* Abnormal renal function\n* Liver function tests greater than two times the upper limit of normal\n* Anemia\n* Use of viagra or other PDE5 inhibitor\n* Hypercholesterolemia\n* Aspirin allergy/sensitivity\n* Asthma with nasal polyps\n* Peptic ulcer disease/Gastrointestinal bleeding\n* Any ongoing drug treatment'}, 'identificationModule': {'nctId': 'NCT00553995', 'briefTitle': 'Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Effect of Physical Inactivity on Endothelial Function', 'orgStudyIdInfo': {'id': 'H-23068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salsalate', 'description': 'Salsalate', 'interventionNames': ['Drug: salsalate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'salsalate', 'type': 'DRUG', 'description': 'Salsalate 3-4 grams per day as tolerated for nine days', 'armGroupLabels': ['Salsalate']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02119', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University School of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Naomi Hamburg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Naomi M Hamburg', 'investigatorAffiliation': 'Boston University'}}}}