The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 40
Updated:2/20/2019
Start Date:January 2016
End Date:March 2020
Contact:Cara Ludwick
Email:cludwick1@partners.org
Phone:617-278-0305

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The purpose of this research protocol is to determine if the same effects are observed in
vivo in humans using a similar approach. Demonstrating that mineralocorticoid acts on zona
glomerulosa cells to regulate aldosterone production in a short feedback loop would provide
important insight into hormone regulation, and explain variability in pathophysiologic states
such as hypertension and cardiovascular diseases.

In order to provide additional evidence indicating the presence of functional and in order to
provide additional evidence indicating the presence of functional mineralocorticoid receptors
(MR) on zona glomerulosa (ZG) cells, the investigators propose the following protocol in
healthy volunteers. The investigators will evaluate aldosterone and cortisol production in
response to an angiotensin II infusion after three separate test conditions: 1) placebo, 2)
following a single dose of fludrocortisone, and 3) following a single dose of eplerenone (a
MR antagonist).

Inclusion Criteria:

- Participants must be healthy, with no prior history of hypertension, no family history
of hypertension, diabetes, stroke or cardiac disease in first-degree relatives before
the age of 70 years and have an average (two measurements) blood pressure of <130/89
mm Hg and >100/50 mmHg at the screening visit.

- All subjects will have body mass index 19-25 kg/m2.

- Subjects must have normal laboratory values for: Complete blood count; serum
creatinine, sodium, potassium, glucose, liver enzymes; urinalysis; negative urine HCG
in women; normal ECG

Exclusion Criteria:

- Alcohol intake >12oz per week, as well as tobacco or recreational drug use.

- Any subject with a history of coronary disease, diabetes, hypertension, stroke, kidney
disease, or illness requiring overnight hospitalization in the past 6 months will be
excluded from the study.

- Subjects taking any prescription medications (with the exception of birth control
pills) or herbal medications will be excluded.

- Because of the unknown risk of infused angiotensin II in pregnancy, women who are
pregnant will be excluded from study and all women will be screened for pregnancy by
quantitative serum hCG measurement on the day of each CCI admission.

- Women currently breastfeeding will also be excluded from the study.
We found this trial at
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Jonathan S Williams, MD, MMSc
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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