Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

• Sponsor: Boston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00553995
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 79
• Patients Per Site Per Month: 0.8

Study Details

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
• 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 1, 2008
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2014

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 [5 days]

Secondary Outcome Measures

1. Reactive hyperemia in the brachial artery [5 days]

2. Oral glucose tolerance test [5 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Boston University School of Medicine	Boston	Massachusetts	United States	02119

Sponsors and Collaborators

• Boston University

Investigators

• Principal Investigator: Naomi Hamburg, MD, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Naomi M Hamburg, Principal Investigator, Boston University
• ClinicalTrials.gov Identifier: NCT00553995
• Other Study ID Numbers: H-23068
• First Posted: Nov 6, 2007
• Last Update Posted: Mar 10, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Insulin Resistance; Salicylsalicylic acid

Study Results

No Results Posted as of Mar 10, 2017