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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Endothelial Function [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Flow-mediated, brachial artery vasodilation (FMD)


Secondary Outcome Measures:
  • Insulin Resistance [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)


Enrollment: 5
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412216

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01412216     History of Changes
Other Study ID Numbers: Sedentarism
Study First Received: August 5, 2011
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 26, 2014