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Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
salsalate
Placebo
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Boston University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Salsalate

Placebo

Arm Description

Salsalate

Placebo

Outcomes

Primary Outcome Measures

Reactive hyperemia in the femoral artery

Secondary Outcome Measures

Reactive hyperemia in the brachial artery
Oral glucose tolerance test

Full Information

First Posted
November 5, 2007
Last Updated
March 8, 2017
Sponsor
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT00553995
Brief Title
Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction
Official Title
Effect of Physical Inactivity on Endothelial Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (Actual)
Primary Completion Date
December 1, 2013 (Actual)
Study Completion Date
December 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salsalate
Arm Type
Experimental
Arm Description
Salsalate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
salsalate
Intervention Description
Salsalate 3-4 grams per day as tolerated for nine days
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Reactive hyperemia in the femoral artery
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Reactive hyperemia in the brachial artery
Time Frame
5 days
Title
Oral glucose tolerance test
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Hamburg, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02119
Country
United States

12. IPD Sharing Statement

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Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

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