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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01024634
Other study ID # UIUC 09599
Secondary ID 1R01HL093249-01A
Status Completed
Phase N/A
First received December 2, 2009
Last updated December 14, 2012
Start date September 2009
Est. completion date December 2012

Study information

Verified date December 2012
Source University of Illinois at Urbana-Champaign
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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date December 2012
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Endurance Exercise
8 weeks of Endurance exercise training, 3-4 times per week, 45-60 minutes perr session

Locations

Country Name City State
United States Kinesiology and Community Health Department, University of Illinois at Urbana-Champaign Urbana Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial function Pre, following a 4 week control period and after 8 weeks of exercise intervention No
Secondary Autonomic function Pre, following a 4 week control period and following 8 weeeks of an exercise intervention No
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