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Pilot Study On The Role Of Nitric Oxide In Alpha 1-Adrenergic Vasoreactivity

Pilot Study On The Role Of Nitric Oxide In Alpha 1-Adrenergic Vasoreactivity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00240058
Enrollment
22
Registered
2005-10-17
Start date
2005-07-31
Completion date
2006-06-30
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

Blood Pressure, Nitric Oxide, L-NMMA, Phenylephrine, Nitroprusside, Vasoreactivity

Brief summary

This is a research project to test two study techniques among healthy adults. The procedures look at how blood flow is controlled by substances in blood vessels.

Detailed description

Most patients with chronic kidney disease (CKD) have high blood pressure and are at high risk for cardiovascular disease. High blood pressure can be partly caused by narrowing of blood vessels from high activity of the alpha1-adrenoceptor system in blood vessels. On the other hand, nitric oxide (NO), produced by the body, opposes the alpha 1-adrenoceptor system. NO widens blood vessels and prevents high blood pressure. We hypothesize that low availability of NO may be responsible for high activity of alpha 1-adrenoceptor system in patients with CKD. This protocol is a pilot study in healthy subjects to guide us in performing future studies in patients with CKD. The specific aims of the pilot study, in healthy people, are to 1) determine whether alpha 1-adrenoceptor vasoreactivity is reproducible and 2) determine alpha 1-adrenoceptor vasoreactivity with the NO clamp technique. To carry out these specific aims, we will consent and enroll healthy people with normal blood pressure. After a screening visit to confirm eligibility, subjects will be admitted to the General Clinical Research Center overnight for a study the following day. We will constrict the forearm blood vessels by giving different amounts of phenylephrine into the artery through a catheter. We will measure the subjects blood flow with venus plethysmography ( a measuring tool like a blood pressure cuff) while giving the phenylephrine. We will repeat the tests to see if we get the same results. Then, a research medication, L-NMMA, which blocks NO in the blood vessel, will be dripped into the same artery followed by another medication nitroprusside, which gives back NO, to restore normal forearm blood flow. This procedure is called the NO clamp technique and is used to measure the effects of NO. The phenylephrine concentrations and plethysmography will be repeated again to compare vessel narrowing before and during the NO clamp. This research will teach us how to perform future studies on the relationship between NO and the alpha 1-adrenoceptor system in patients with kidney disease.

Interventions

DRUGRegional phenylephrine arterial infusion, Nitric Oxide Clamp

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Michigan
CollaboratorOTHER
Crystal A. Gadegbeku
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy men and women: * Age 18 to 55 years * Who have Blood Pressure less than or equal to 120/80.

Exclusion criteria

Individuals with: * Diabetes, lung disease * Stomach disease, liver disease * Blood vessel disease * Kidney disease * High blood pressure * Heart disease * Hereditary blood disorders * Hematocrit (amount of red blood cells) less than 30%, * Who smoke * Women who are pregnant or lactating

Design outcomes

Primary

MeasureTime frame
Determine whether alpha 1-adrenoceptor vasoreactivity is reproducible
Determine alpha 1-adrenoceptor vasoreactivity with the NO clamp technique

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026