- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024634
Vascular and Neuro-inflammatory Effects of Endurance Exercise Training in African Americans (VINE)
December 14, 2012 updated by: Bo Fernhall, University of Illinois at Urbana-Champaign
The purpose of this study is to test the effects of endurance exercise training on arterial structure and function, and to examine potential mechanisms producing changes in arterial structure and function in young (18-35 years of age) African Americans when compared to Caucasians.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
African-Americans are at greater risk than Caucasians for developing hypertension, cardiovascular disease, stroke and renal disease.
This is likely related to arterial dysfunction including greater arterial stiffness, and reduced microvascular reactivity of resistance arteries in African-Americans.
In addition, African-Americans have higher levels of inflammatory markers, and a greater sympathoexcitatory response to various stressors.
This imbalance between sympathetic and reduced parasympathetic activation may directly affect vascular function and potentiate a greater inflammatory response, further altering key structural and functional properties of the vascular wall.
The overall aim of this proposal is to test the effects of endurance exercise training on arterial structure and function, and to examine potential mechanisms producing changes in arterial structure and function in young (18-35 years of age) African Americans when compared to Caucasians.
We will examine these effects at rest and following a high intensity (maximal cycle ergometry) sympathoexcitation at both pre- and post-intervention time points, since sympathoexcitation may elucidate changes not evident at rest.
Because African-Americans have higher levels of arterial stiffness, lower microvascular reactivity, greater responses to sympathoexcitation, greater levels of inflammatory markers and greater vasoconstrictive tone, we hypothesize that African-Americans will show differential responses to exercise training and benefit more compared to a matched group of Caucasians.
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- Kinesiology and Community Health Department, University of Illinois at Urbana-Champaign
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects in good health with no cardiovascular, metabolic, or inflammatory disease, who do not use cardiovascular medications or antioxidant vitamin supplementation, including use of anti-inflammatory (including aspirin) or steroidal substances in the past 2 months will be inlcuded
Exclusion Criteria:
- Subjects who smoke, are severely obese (body mass index > 35 kg/m2), or who have hypertension (blood pressure >140/90mmHg), diabetes (fasting glucose >110mg/dl), hyperlipidemia, inflammatory disease (rheumatoid arthritis and systemic lupus erythematosus, etc) or diagnosed cardiovascular disease including, coronary heart disease, hypertension and cardiac arrhythmia or renal disease, will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: African American Group
A group of young African American males and females
|
8 weeks of Endurance exercise training, 3-4 times per week, 45-60 minutes perr session
|
Other: Caucasian Group
a group of young Caucasian men and women
|
8 weeks of Endurance exercise training, 3-4 times per week, 45-60 minutes perr session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arterial function
Time Frame: Pre, following a 4 week control period and after 8 weeks of exercise intervention
|
Pre, following a 4 week control period and after 8 weeks of exercise intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Autonomic function
Time Frame: Pre, following a 4 week control period and following 8 weeeks of an exercise intervention
|
Pre, following a 4 week control period and following 8 weeeks of an exercise intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Bo Fernhall, Ph.D., University of Illinois at Urbana-Champaign
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
December 2, 2009
First Submitted That Met QC Criteria
December 2, 2009
First Posted (Estimate)
December 3, 2009
Study Record Updates
Last Update Posted (Estimate)
December 17, 2012
Last Update Submitted That Met QC Criteria
December 14, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- UIUC 09599
- 1R01HL093249-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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