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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
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Insulin Resistance Metabolic Syndrome Peripheral Arterial Disease Dietary Supplement: Fish Oil (Omega-3 Fatty Acids) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
Study Start Date : September 2011
Primary Completion Date : November 2013
Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: Fish Oil (Omega-3 Fatty Acids)
High-dose, short-duration dietary omega-3 fatty acids supplementation
Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
fish oil-4.4gm/day x 5 days
Placebo Comparator: Placebo
Placebo control
Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)

Primary Outcome Measures :
  1. Endothelial Function [ Time Frame: 5 days ]
    Flow-mediated, brachial artery vasodilation (FMD)

Secondary Outcome Measures :
  1. Insulin Resistance [ Time Frame: 5 days ]
    The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412216

United States, California
University of California San Francisco
San Francisco, California, United States
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Marlene Grenon, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01412216     History of Changes
Other Study ID Numbers: Sedentarism
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013

Keywords provided by University of California, San Francisco:
Physical inactivity
Fish oil
Omega-3 fatty acids
Endothelial dysfunction
Insulin resistance
Metabolic syndrome
peripheral arterial disease

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs