Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
salsalate
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Pregnancy
- History of Coronary Artery Disease
- Diabetes Mellitus
- Hypertension
- Cigarette smoking
- History or family history of deep vein thrombosis or pulmonary embolism
- Abnormal renal function
- Liver function tests greater than two times the upper limit of normal
- Anemia
- Use of viagra or other PDE5 inhibitor
- Hypercholesterolemia
- Aspirin allergy/sensitivity
- Asthma with nasal polyps
- Peptic ulcer disease/Gastrointestinal bleeding
- Any ongoing drug treatment
Sites / Locations
- Boston University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Salsalate
Placebo
Arm Description
Salsalate
Placebo
Outcomes
Primary Outcome Measures
Reactive hyperemia in the femoral artery
Secondary Outcome Measures
Reactive hyperemia in the brachial artery
Oral glucose tolerance test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00553995
Brief Title
Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction
Official Title
Effect of Physical Inactivity on Endothelial Function
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (Actual)
Primary Completion Date
December 1, 2013 (Actual)
Study Completion Date
December 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salsalate
Arm Type
Experimental
Arm Description
Salsalate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
salsalate
Intervention Description
Salsalate 3-4 grams per day as tolerated for nine days
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Reactive hyperemia in the femoral artery
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Reactive hyperemia in the brachial artery
Time Frame
5 days
Title
Oral glucose tolerance test
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Exclusion Criteria:
Pregnancy
History of Coronary Artery Disease
Diabetes Mellitus
Hypertension
Cigarette smoking
History or family history of deep vein thrombosis or pulmonary embolism
Abnormal renal function
Liver function tests greater than two times the upper limit of normal
Anemia
Use of viagra or other PDE5 inhibitor
Hypercholesterolemia
Aspirin allergy/sensitivity
Asthma with nasal polyps
Peptic ulcer disease/Gastrointestinal bleeding
Any ongoing drug treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Hamburg, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02119
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction
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