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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00240058
First received: October 13, 2005
Last updated: November 2, 2006
Last verified: November 2006

October 13, 2005
November 2, 2006
July 2005
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  • Determine whether alpha 1-adrenoceptor vasoreactivity is reproducible
  • Determine alpha 1-adrenoceptor vasoreactivity with the NO clamp technique
  • 1) Determine whether alpha 1-adrenoceptor vasoreactivity is reproducible
  • 2) Determine alpha 1-adrenoceptor vasoreactivity with the NO clamp technique
Complete list of historical versions of study NCT00240058 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Blood Pressure
Procedure: Regional phenylephrine arterial infusion, Nitric Oxide Clamp
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2006
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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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00240058
DRDA05-0222, NIH # 1R33 DK 071222-01
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University of Michigan
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Crystal A Gadegbeku, MD Assistant Professor of Medicine, University of Michigan Health System, Department of Internal Medicine, Division of Nephrology
University of Michigan
November 2006

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