Blood PressureNCT00240058
Pilot Study On The Role Of Nitric Oxide In Alpha 1-Adrenergic Vasoreactivity
A study testing Regional phenylephrine arterial infusion, Nitric Oxide Clamp in people with Blood Pressure, run by Crystal A. Gadegbeku at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Regional phenylephrine arterial infusion, Nitric Oxide Clamp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women:
- Age 18 to 55 years
- Who have Blood Pressure less than or equal to 120/80.
Who cannot join
- Individuals with:
- Diabetes, lung disease
- Stomach disease, liver disease
- Blood vessel disease
- Kidney disease
- High blood pressure
Show all 11Show fewer
- Heart disease
- Hereditary blood disorders
- Hematocrit (amount of red blood cells) less than 30%,
- Who smoke
- Women who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- Regional phenylephrine arterial infusion, Nitric Oxide Clamp
- Keywords
- Blood Pressure, Nitric Oxide, L-NMMA, Phenylephrine, Nitroprusside, Vasoreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional phenylephrine arterial infusion, Nitric Oxide ClampDrug
| Study group | Role | What they receive |
|---|---|---|
| phenylephrine infusion with and without nitric oxide clamp | Other | Participants received phenylephrine infusion with saline followed by phenylephrine infusion with nitric oxide clamp Receives: Drug: Regional phenylephrine arterial infusion, Nitric Oxide Clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether alpha 1-adrenoceptor vasoreactivity is reproducible
Determine alpha 1-adrenoceptor vasoreactivity with the NO clamp technique
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crystal A. Gadegbeku
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan
- Responsible party
- Sponsor-investigator, Crystal A. Gadegbeku, University of Michigan
- Investigators
- Crystal A Gadegbeku, MD, Principal investigator, Assistant Professor of Medicine, University of Michigan Health System, Department of Internal Medicine, Division of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240058
- Sponsor's protocol ID
- DRDA05-0222
- Other IDs
- R33DK071222
- Status last verified
- Jun 2017
- First submitted
- 13 Oct 2005
- Last updated
- 5 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study On The Role Of Nitric Oxide In Alpha 1-Adrenergic Vasoreactivity
- ClinicalTrials.gov ID
- NCT00240058
- Acronym / sponsor ID
- DRDA05-0222
- Conditions
- Blood Pressure
- Keywords
- Blood Pressure, Nitric Oxide, L-NMMA, Phenylephrine, Nitroprusside, Vasoreactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Crystal A. GadegbekuUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan
- Study start
- Jul 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| phenylephrine infusion with and without nitric oxide clamp | Other | Drug: Regional phenylephrine arterial infusion, Nitric Oxide ClampParticipants received phenylephrine infusion with saline followed by phenylephrine infusion with nitric oxide clamp |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 55 years
- Who have Blood Pressure less than or equal to 120/80.
Key exclusion criteria (11 listed)
- Diabetes, lung disease
- Stomach disease, liver disease
- Blood vessel disease
- Kidney disease
- High blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional phenylephrine arterial infusion, Nitric Oxide Clamp | Drug | phenylephrine infusion with and without nitric oxide clamp |
Primary outcome
Determine whether alpha 1-adrenoceptor vasoreactivity is reproducible
Determine alpha 1-adrenoceptor vasoreactivity with the NO clamp technique
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Principle Investigator research informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal A Gadegbeku, MD principal investigator
Assistant Professor of Medicine, University of Michigan Health System, Department of Internal Medicine, Division of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional phenylephrine arterial infusion, Nitric Oxide Clamp in people with Blood Pressure, run by Crystal A. Gadegbeku at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether alpha 1-adrenoceptor vasoreactivity is reproducible. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.