Clinical trial NCT02123069: Vascular Function and Uterine Fibroids
Official title: Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leiomyoma
Keywords: Autonomic nervous system
Blood pressure
Blood vessels
Physiological effects of drugs
Vascular stiffness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 28
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal women, ages 25-50 years old, who have and have not been diagnosed with uterine fibroids. Women will be recruited from Rochester, Minnesota and the surrounding area (including locations in Iowa and Wisconsin). Women eligible to participate will be in good health and not taking medications.

Brief summary: The purpose of this study is to learn how uterine fibroids may be connected to heart disease and high blood pressure. It is not known what causes fibroids, but they frequently occur in women who also have high blood pressure, heart disease, and stroke. The investigators of this study want to learn if certain changes in the blood vessels or nerve activity can put women at risk for these diseases and for fibroids.

Detailed description: The investigators are inviting women, 25-50 years old, who have not gone through menopause to participate in this study. The investigators are looking for some women with uterine fibroids and some without uterine fibroids based on ultrasound or MRI. If the patients have not had a recent ultrasound or MRI of the uterus, a physician can provide one.

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.

Eligibility criteria: Inclusion Criteria:

* Women 25-50 years old
* Premenopausal

Exclusion Criteria:

* Postmenopausal
* 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

Primary outcomes:
measure: Baseline systolic, diastolic, and mean blood pressures
timeFrame: One day (study day)
measure: Baseline sympathetic nerve activity
timeFrame: One day (study day)
Secondary outcomes:
measure: Changes in forearm blood flow levels in response to acetylcholine infusion
timeFrame: One day (study day)
measure: Changes in forearm blood flow levels in response to nitroprusside infusion
timeFrame: One day (study day)
measure: Changes in forearm blood flow levels in response to norepinephrine infusion
timeFrame: One day (study day)
measure: Change in blood pressure in response to infusions of nitroprusside and phenylephrine
timeFrame: One day (study)
measure: Pulse wave velocity (an index of vessel stiffness)
timeFrame: One day (study day)
Other outcomes:
measure: Female sex hormone levels
timeFrame: One day (study day)
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael J Joyner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: