Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction - Full Text View

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

ChemIDplus related topics:

Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Official Title:	Effect of Physical Inactivity on Endothelial Function

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 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Salsalate 3-4 grams per day as tolerated for nine days

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

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

Contacts


Contact: Joseph A Vita, MD	617-638-8742	jvita@bu.edu

Locations


United States, Massachusetts
	Boston University School of Medicine	Recruiting
	Boston, Massachusetts, United States, 02119
	Principal Investigator: Joseph A Vita, MD

Sponsors and Collaborators

Boston University

Investigators


Principal Investigator:	Joseph A Vita, MD	Boston Medical Center

More Information

Responsible Party:	Boston University School of Medicine ( Joseph A. Vita, MD )
Study ID Numbers:	H-23068
First Received:	November 5, 2007
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00553995
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hyperinsulinism

Metabolic Diseases

Salicylsalicylic acid

Salicylates

Sodium Salicylate

Insulin Resistance

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Boston University
Information provided by:	Boston University
ClinicalTrials.gov Identifier:	NCT00553995