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

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ClinicalTrials.gov Identifier: NCT01412216
Recruitment Status : Terminated (Funding Depleted.)
First Posted : August 9, 2011
Last Update Posted : November 7, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 5, 2011
First Posted Date  ICMJE August 9, 2011
Last Update Posted Date November 7, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2011)
Endothelial Function [ Time Frame: 5 days ]
Flow-mediated, brachial artery vasodilation (FMD)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2013)
Insulin Resistance [ Time Frame: 5 days ]
The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2011)
Insulin Resistance [ Time Frame: 5 days ]
HOMA-IR
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
Official Title  ICMJE The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Endothelial Dysfunction
  • Insulin Resistance
  • Metabolic Syndrome
  • Peripheral Arterial Disease
Intervention  ICMJE
  • Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
    fish oil-4.4gm/day x 5 days
  • Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 6, 2013)
5
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2011)
16
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01412216
Other Study ID Numbers  ICMJE Sedentarism
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marlene Grenon, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2013

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