Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

Insulin Resistance Clinical Trial

Official title:

Effect of Physical Inactivity on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553995
• Other study ID #: H-23068
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2007
• Last updated: March 8, 2017
• Start date: May 2008
• Est. completion date: December 1, 2014

Study information

• Verified date: March 2017
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2014
• Est. primary completion date: December 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Drug:
• salsalate
Salsalate 3-4 grams per day as tolerated for nine days
• Placebo

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactive hyperemia in the femoral artery		5 days
Secondary	Reactive hyperemia in the brachial artery		5 days
Secondary	Oral glucose tolerance test		5 days