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Clinical Trials/NCT00553995
NCT00553995
Completed
Phase 1

Effect of Physical Inactivity on Endothelial Function

Boston University1 site in 1 country60 target enrollmentMay 2008

Overview

Phase
Phase 1
Intervention
salsalate
Conditions
Insulin Resistance
Sponsor
Boston University
Enrollment
60
Locations
1
Primary Endpoint
Reactive hyperemia in the femoral artery
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
December 1, 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Naomi M Hamburg

Principal Investigator

Boston University

Eligibility 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
  • Use of viagra or other PDE5 inhibitor
  • Hypercholesterolemia

Arms & Interventions

Salsalate

Salsalate

Intervention: salsalate

Placebo

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Reactive hyperemia in the femoral artery

Time Frame: 5 days

Secondary Outcomes

  • Reactive hyperemia in the brachial artery(5 days)
  • Oral glucose tolerance test(5 days)

Study Sites (1)

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