Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
28 participants
OBSERVATIONAL
2013-04-30
2018-03-01
Brief Summary
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Detailed Description
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Individuals cannot participate if they have high blood pressure, diabetes, or disease in the kidneys, lungs, or blood vessels. Also, individuals who smoke, have high cholesterol, or are obese (BMI is higher than 30) cannot participate. Certain medications, including high blood pressure medications, beta-blockers and anti-depressants, will also limit potential patient participation. The investigators would be happy to review medications for potential participants.
Screen Day:
One of the members of the research team will review the study and the informed consent document with the patient. The patient will have their height, weight, blood pressure, pulse and respirations measured. The patient will also complete three questionnaires. If the patient has not had an ultrasound of the uterus in the last 12 months, a physician will complete one for her.
Study Day:
The patient will need to fast overnight (no eating or drinking). The investigators will draw a blood sample and then do a series of tests on the participant's blood vessels. For some of the tests, medication will be given through an IV. The investigators will also test nerve activity in the nerve on the outer aspect of the leg.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Women with uterine fibroids
* Brachial artery catheter
* Acetylcholine
* Nitroprusside
* Norepinephrine
* Nitroprusside and phenylephrine
Brachial artery catheter
A catheter will be placed in the brachial artery by a physician on the study day.
Acetylcholine
Acetylcholine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Acetylcholine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.
Nitroprusside
Nitroprusside will be infused into the brachial catheter while blood flow levels in the forearm are measured. Nitroprusside will be infused at the following doses: 0.25, 0.5, 1.0, and 2.0 ug/100 ml tissue/min for 2 minutes each.
Norepinephrine
Norepinephrine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Norepinephrine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.
Nitroprusside and phenylephrine
A single dose of nitroprusside (100 ug) will be infused through an IV; one minute later, a single dose of phenylephrine (150 ug) will be infused.
Women without uterine fibroids
* Brachial artery catheter
* Acetylcholine
* Nitroprusside
* Norepinephrine
* Nitroprusside and phenylephrine
Brachial artery catheter
A catheter will be placed in the brachial artery by a physician on the study day.
Acetylcholine
Acetylcholine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Acetylcholine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.
Nitroprusside
Nitroprusside will be infused into the brachial catheter while blood flow levels in the forearm are measured. Nitroprusside will be infused at the following doses: 0.25, 0.5, 1.0, and 2.0 ug/100 ml tissue/min for 2 minutes each.
Norepinephrine
Norepinephrine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Norepinephrine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.
Nitroprusside and phenylephrine
A single dose of nitroprusside (100 ug) will be infused through an IV; one minute later, a single dose of phenylephrine (150 ug) will be infused.
Interventions
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Brachial artery catheter
A catheter will be placed in the brachial artery by a physician on the study day.
Acetylcholine
Acetylcholine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Acetylcholine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.
Nitroprusside
Nitroprusside will be infused into the brachial catheter while blood flow levels in the forearm are measured. Nitroprusside will be infused at the following doses: 0.25, 0.5, 1.0, and 2.0 ug/100 ml tissue/min for 2 minutes each.
Norepinephrine
Norepinephrine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Norepinephrine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.
Nitroprusside and phenylephrine
A single dose of nitroprusside (100 ug) will be infused through an IV; one minute later, a single dose of phenylephrine (150 ug) will be infused.
Eligibility Criteria
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Inclusion Criteria
* Premenopausal
Exclusion Criteria
* Pregnant or currently breastfeeding
* Using blood pressure medications or anti-depression medications
* High blood pressure
* Diabetes
* Disease in the kidneys, lungs, or blood vessels
* Chronic diseases (for example: Crohn's disease, rheumatoid arthritis, bipolar mood disorder, etc.)
* Smoker
* High cholesterol
* BMI higher than 30
25 Years
50 Years
FEMALE
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Michael J. Joyner, M.D.
PI
Principal Investigators
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Michael J Joyner, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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13-000596
Identifier Type: -
Identifier Source: org_study_id
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