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

Phase 2

Terminated

• Conditions: Peripheral Arterial Disease; Insulin Resistance; Metabolic Syndrome; Endothelial Dysfunction
• Interventions: Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)

• Registration Number: NCT01412216
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Study Start: 2011-09
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish Oil (Omega-3 Fatty Acids)	Fish Oil (Omega-3 Fatty Acids)	High-dose, short-duration dietary omega-3 fatty acids supplementation
Placebo	Fish Oil (Omega-3 Fatty Acids)	Placebo control

Primary Outcome Measures

Name	Time	Method
Endothelial Function	5 days	Flow-mediated, brachial artery vasodilation (FMD)

Secondary Outcome Measures

Name	Time	Method
Insulin Resistance	5 days	The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States