This trial is active, not recruiting.

Condition insulin resistance
Treatments salsalate, placebo
Sponsor Boston University
Start date May 2008
End date December 2013
Trial size 40 participants
Trial identifier NCT00553995, H-23068


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Salsalate 3-4 grams per day as tolerated for nine days
(Placebo Comparator)

Primary Outcomes

Reactive hyperemia in the femoral artery
time frame: 5 days

Secondary Outcomes

Reactive hyperemia in the brachial artery
time frame: 5 days
Oral glucose tolerance test
time frame: 5 days

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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

Additional Information

Official title Effect of Physical Inactivity on Endothelial Function
Principal investigator Joseph A Vita, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Boston University.