Forearm Vascular Relaxation - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

August 28, 2008

Start Date ^ICMJE

May 2003

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00182923 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Forearm Vascular Relaxation

Official Title ^ICMJE

Determinants of Forearm Vascular Relaxation: Role of Genetic Polymorphisms

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 A brachial artery line and venous line will be placed in the study arm so that blood samples may be withdrawn to compare amounts given into the artery and coming out of the vein after circulating through the arm.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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Prospective

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00182923

Responsible Party

Study ID Numbers ^ICMJE

AG0038

Study Sponsor ^ICMJE

National Institute on Aging (NIA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Darrell R. Abernethy, MD, PhD

National Institute on Aging, Laboratory of Clinical Investigation

Information Provided By

National Institute on Aging (NIA)

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP