Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

Boston University

Status and phase: Completed; Phase 1

Conditions: Insulin Resistance

Treatments: Drug: salsalate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00553995

H-23068

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Salsalate

Experimental group

Description:

Salsalate

Treatment:

Drug: salsalate

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo