NCT00240058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

October 13, 2005

Last Update Submit

June 1, 2017

Conditions

Blood Pressure

Keywords

Blood PressureNitric OxideL-NMMAPhenylephrineNitroprussideVasoreactivity

Outcome Measures

Primary Outcomes (2)

  • Determine whether alpha 1-adrenoceptor vasoreactivity is reproducible

  • Determine alpha 1-adrenoceptor vasoreactivity with the NO clamp technique

Study Arms (1)

phenylephrine infusion with and without nitric oxide clamp

OTHER

Participants received phenylephrine infusion with saline followed by phenylephrine infusion with nitric oxide clamp

Drug: Regional phenylephrine arterial infusion, Nitric Oxide Clamp

Interventions

Regional phenylephrine arterial infusion, Nitric Oxide ClampDRUG
phenylephrine infusion with and without nitric oxide clamp

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Links

Study Officials

  • Crystal A Gadegbeku, MD

    Assistant Professor of Medicine, University of Michigan Health System, Department of Internal Medicine, Division of Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

July 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

June 5, 2017

Record last verified: 2017-06

Locations

US(1)