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

This study has been terminated.
(Funding Depleted.)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01412216
First received: August 5, 2011
Last updated: November 6, 2013
Last verified: November 2013

August 5, 2011
November 6, 2013
September 2011
November 2013   (final data collection date for primary outcome measure)
Endothelial Function [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Flow-mediated, brachial artery vasodilation (FMD)
Same as current
Complete list of historical versions of study NCT01412216 on ClinicalTrials.gov Archive Site
Insulin Resistance [ Time Frame: 5 days ] [ Designated as safety issue: No ]
The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)
Insulin Resistance [ Time Frame: 5 days ] [ Designated as safety issue: No ]
HOMA-IR
Not Provided
Not Provided
 
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Endothelial Dysfunction
  • Insulin Resistance
  • Metabolic Syndrome
  • Peripheral Arterial Disease
  • Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
    fish oil-4.4gm/day x 5 days
  • Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
  • Experimental: Fish Oil (Omega-3 Fatty Acids)
    High-dose, short-duration dietary omega-3 fatty acids supplementation
    Intervention: Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
  • Placebo Comparator: Placebo
    Placebo control
    Intervention: Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01412216
Sedentarism
Not Provided
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Marlene Grenon, MD University of California, San Francisco
University of California, San Francisco
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP