Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

NCT ID: NCT00553995

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2014-12-01

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.

Conditions

Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Salsalate

Salsalate

Group Type: EXPERIMENTAL

salsalate

Intervention Type: DRUG

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

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

salsalate

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

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Naomi M Hamburg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naomi Hamburg, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston University School of Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-23068

Identifier Type: -

Identifier Source: org_study_id