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
  Purpose

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.


Condition Intervention
Insulin Resistance
Drug: salsalate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Physical Inactivity on Endothelial Function

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Reactive hyperemia in the femoral artery [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Salsalate
Salsalate
Drug: salsalate
Salsalate 3-4 grams per day as tolerated for nine days
Placebo Comparator: Placebo
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00553995

Locations
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02119
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Joseph A Vita, MD Boston Medical Center
  More Information

No publications provided

Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University
ClinicalTrials.gov Identifier: NCT00553995     History of Changes
Other Study ID Numbers: H-23068
Study First Received: November 5, 2007
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Sodium Salicylate
Salicylsalicylic acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 14, 2014