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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01169831
Other study ID # HP-00045413
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 2011
Est. completion date December 31, 2023

Study information

Verified date April 2023
Source Baltimore VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which are important for maintaining cardiovascular health. The prevalence of cardiovascular disease in older adults is associated with reduced circulating EPC numbers. Studies have shown reduced EPC number and function in old vs. young individuals, and endurance exercise training increases EPC number and function in young adults. Oxidative stress adversely affects endothelial cells and preliminary evidence indicates that oxidative stress negatively affects EPC function. Conversely, regular exercise reduces markers of oxidative stress and may enhance EPC function in older adults. The investigators hypothesize that older endurance-trained athletes and matched sedentary individuals will have markedly divergent EPC function and that altering the physical activity levels of both groups will move them to intermediate points between these two extremes. The investigators also propose that the investigators can "mimic" the effect of exercise training on EPC function in cell culture by altering intracellular levels of a key enzyme and a signaling molecule which the investigators have shown to regulate EPC function with respect to exercise training in young individuals.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - 50-80 years of age, BMI = 18-35 kg/m2, non-smoking, women must be postmenopausal Exclusion Criteria: - history of cardiovascular/cerebrovascular disease, diabetes, cancer, renal, liver disease, HIV; uncontrolled hyperlipidemia/hypertension

Study Design


Intervention

Other:
Exercise Training
2 weeks of daily aerobic exercise training
Exercise Cessation
Stopping all exercise for 2 weeks

Locations

Country Name City State
United States University of Maryland, Baltimore & Baltimore VA Medical Center Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
Baltimore VA Medical Center University of Maryland, Baltimore, University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline Endothelial progenitor cell number Day 1
Primary Final Endothelial Progenitor Cell Number Day 15
Secondary Baseline Endothelial Reactivity Day 1
Secondary Final Endothelial Reactivity Day 15
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