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Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553995
First Posted: November 6, 2007
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Naomi M Hamburg, Boston University
November 5, 2007
November 6, 2007
March 10, 2017
May 2008
December 1, 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
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
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Completed
60
December 1, 2014
December 1, 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)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00553995
H-23068
No
Not Provided
Not Provided
Naomi M Hamburg, Boston University
Boston University
Not Provided
Principal Investigator: Naomi Hamburg, MD Boston Medical Center
Boston University
March 2017

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