Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

NCT00553995 | Completed Phase 1

• 1 other identifier: H-23068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reactive hyperemia in the femoral artery

  5 days

Secondary Outcomes (2)

• Reactive hyperemia in the brachial artery

  5 days

• Oral glucose tolerance test

  5 days

Study Arms (2)

Salsalate

EXPERIMENTAL

Salsalate

Drug: salsalate

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

salsalate DRUG

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

Salsalate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02119, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

salicylsalicylic acid

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Naomi Hamburg, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: May 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

US (1)