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Completed

NCT Number: NCT00553995

Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston University School of Medicine

Boston, Massachusetts, 02119, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salsalate

Drug

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

Placebo

Drug

Primary outcomes

  1. Reactive hyperemia in the femoral artery

    Time frame: 5 days

Secondary outcomes

  1. Reactive hyperemia in the brachial artery

    Time frame: 5 days

  2. Oral glucose tolerance test

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

Effect of Physical Inactivity on Endothelial Function

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Nov 6, 2007
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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