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Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

Effect of Physical Inactivity on Endothelial Function

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00553995
Enrollment
60
Registered
2007-11-06
Start date
2008-05-31
Completion date
2014-12-01
Last updated
2017-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

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.

Interventions

DRUGsalsalate

Salsalate 3-4 grams per day as tolerated for nine days

DRUGPlacebo

Sponsors

Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Reactive hyperemia in the femoral artery5 days

Secondary

MeasureTime frame
Reactive hyperemia in the brachial artery5 days
Oral glucose tolerance test5 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026