Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier:
First received: November 5, 2007
Last updated: July 23, 2013
Last verified: July 2013

November 5, 2007
July 23, 2013
May 2008
December 2013   (Final data collection date for primary outcome measure)
Reactive hyperemia in the femoral artery [ Time Frame: 5 days ]
Same as current
Complete list of historical versions of study NCT00553995 on ClinicalTrials.gov Archive Site
  • Reactive hyperemia in the brachial artery [ Time Frame: 5 days ]
  • Oral glucose tolerance test [ Time Frame: 5 days ]
Same as current
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Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction
Effect of Physical Inactivity on Endothelial Function
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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Insulin Resistance
  • Drug: salsalate
    Salsalate 3-4 grams per day as tolerated for nine days
  • Drug: Placebo
  • Experimental: Salsalate
    Intervention: Drug: salsalate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Joseph A. Vita, Boston University
Boston University
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Principal Investigator: Joseph A Vita, MD Boston Medical Center
Boston University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP