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

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

Study Description

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 Design

• 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
• Actual Primary Completion Date: November 2013
• Actual Study Completion Date: November 2013

Arms and Interventions

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)

Outcome Measures

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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

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

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:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Metabolic Syndrome; Insulin Resistance; Inflammation; Pathologic Processes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases