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

Metabolic Syndrome Clinical Trial

— Bedrest  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01412216
• Other study ID #: Sedentarism
• Status: Terminated
• Phase: Phase 2
• First received: August 5, 2011
• Last updated: November 6, 2013
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Dietary Supplement:
• Fish Oil (Omega-3 Fatty Acids)
fish oil-4.4gm/day x 5 days
• Fish Oil (Omega-3 Fatty Acids)

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	Flow-mediated, brachial artery vasodilation (FMD)	5 days	No
Secondary	Insulin Resistance	The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)	5 days	No