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Clinical Trials/NCT01412216
NCT01412216
Terminated
Phase 2

The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance

University of California, San Francisco1 site in 1 country5 target enrollmentSeptember 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Endothelial Dysfunction
Sponsor
University of California, San Francisco
Enrollment
5
Locations
1
Primary Endpoint
Endothelial Function
Status
Terminated
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study are twofold:

  1. To understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation;
  2. To assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation.
Registry
clinicaltrials.gov
Start Date
September 2011
End Date
November 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy subjects: Subjects must be free from any acute, chronic or debilitating medical conditions. Healthy status will be established on the basis of clinical history, electrocardiogram, clinical biochemical screening tests of blood and urine, a physical examination, and where necessary a chest radiograph.

Exclusion Criteria

  • Any active acute or chronic medical problem: Any subject with symptoms of active illness (e.g., fever, leukocytosis, hypertension) will be excluded from study. The exclusion criteria will also include history or evidence for psychiatric disorders, hypertension, diabetes, coronary artery disease (CAD), renal insufficiency, thyroid disease, alcohol or drug abuse, viral hepatitis, deep venous thrombosis or anemia. Individuals with a history of psychiatric illnesses or psychiatric disorders will also be excluded, such as alcoholism, drug dependency including dependency on tobacco, major mood disorders such as major depression and manic depressive illness, schizophrenic disorders, anxiety disorders including panic disorder, generalized anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder. In addition, potential subjects with a first order relative with a history of major depressive illness, manic depressive illness, schizophrenia, agoraphobia or panic disorder will also be excluded from entry to this study. Finally, individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressant, neuroleptic medications or major tranquilizers will be excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) will not necessarily be exclusionary.

Outcomes

Primary Outcomes

Endothelial Function

Time Frame: 5 days

Flow-mediated, brachial artery vasodilation (FMD)

Secondary Outcomes

  • Insulin Resistance(5 days)

Study Sites (1)

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