Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier:
NCT00553995
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 ] [ Designated as safety issue: No ]
Reactive hyperemia in the femoral artery [ Time Frame: 5 days ]
Complete list of historical versions of study NCT00553995 on ClinicalTrials.gov Archive Site
  • Reactive hyperemia in the brachial artery [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Oral glucose tolerance test [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Reactive hyperemia in the brachial artery [ Time Frame: 5 days ]
  • Oral glucose tolerance test [ Time Frame: 5 days ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
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
    Salsalate
    Intervention: Drug: salsalate
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00553995
H-23068
No
Joseph A. Vita, Boston University
Boston University
Not Provided
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