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Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

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ClinicalTrials.gov Identifier: NCT00553995
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Insulin Resistance Drug: salsalate Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Physical Inactivity on Endothelial Function
Actual Study Start Date : May 2008
Primary Completion Date : December 1, 2013
Study Completion Date : December 1, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Salsalate
Salsalate
Drug: salsalate
Salsalate 3-4 grams per day as tolerated for nine days
Placebo Comparator: Placebo
Placebo
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Reactive hyperemia in the femoral artery [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Reactive hyperemia in the brachial artery [ Time Frame: 5 days ]
  2. Oral glucose tolerance test [ Time Frame: 5 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553995


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

Responsible Party: Naomi M Hamburg, Principal Investigator, Boston University
ClinicalTrials.gov Identifier: NCT00553995     History of Changes
Other Study ID Numbers: H-23068
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

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