Forearm Vascular Relaxation

Completed

• Conditions: Healthy

• Registration Number: NCT00182923
• Lead Sponsor: National Institute on Aging (NIA)

Brief Summary

The purpose of this study is to learn the effect of inherited differences on forearm blood flow responses to hormones and drugs

Detailed Description

Differences in at least 4 genes are believed to have an important effect on responses to hormones and drugs. For this study, healthy volunteers of normal body weight will be screened to find xxx individuals with the genes of interest. Very small doses of hormones and drugs will be given so that changes in forearm blood flow can be measured, while not causing effects throughout the body. A brachial artery line and venous line will be placed in the study arm so that blood samples may be withdrawn to compare amounts given into the artery and coming out of the vein after circulating through the arm. Forearm blood flow is determined by the rate of swelling of the arm after a blood pressure cuff is inflated (above venous and below arterial blood pressure). The hormones and drugs being studied include angiotensin I, angiotensin II, acetylcholine, sodium nitroprusside, enalaprilat, L-arginine, phenylephrine, endothelin-1, verapamil, and isoproterenol. This procedure will last 4-6 hours. The process will be repeated with the same participant over 2 weeks later.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-28
• Last Update Posted: 2008-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Normal physical status without any medical interventions or agents which would alter the defined status of normal

Exclusion Criteria

• Age less than 21 or greater than 45
• Unable to give informed consent
• BMI (Body Mass Index) less than 18 or greater than 25
• Clinically significant abnormal laboratory values
• Abnormal physical exam
• Abnormal EKG
• Pregnancy
• Smoking or drug usage (illicit or otherwise)
• Post-menopause
• Participation in another clinical trial in the past month
• Chronic Illness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institute on Aging (NIA), Harbor Hospital; 🇺🇸 Baltimore, Maryland, United States