Hypoglycemia and the Mineralocorticoid Receptor
Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypoglycemia
Intervention: Eplerenone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s):
Ajaykumar D Rao, MD, Study Chair, Affiliation: Brigham and Women's Hospital
Gail K Adler, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Overall contact:
Ajaykumar D Rao, MD, Phone: 617-732-8315, Email: adrao@partners.org
Summary
The purpose of this study is to look at whether blockade of the mineralocorticoid receptor
will result in changes in the cardiovascular and inflammatory response to hypoglycemia.
Clinical Details
Official title: Hypoglycemia and the Mineralocorticoid Receptor
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Change from Baseline in Cardiovascular Autonomic Function
Secondary outcome: Change from Baseline in Inflammation
Detailed description:
The effect of ongoing hypoglycemia on cardiovascular autonomic function is unclear and the
focus of this protocol. In our preliminary studies, the investigators demonstrated that
baroreflex sensitivity is impaired during hypoglycemia in healthy individuals. Treatment
with eplerenone (200mg total administered in two doses in the 15 hours prior to the
hypoglycemic clamp) prevented this impairment.
The study is based on the overarching hypothesis that hypoglycemia leads to increases in
aldosterone/mineralocorticoid receptor (MR) activity and increased cardiovascular injury.
This study will address the following Specific Aim:
To test the hypothesis that MR blockade will reduce the adverse effects of hypoglycemia on
inflammation and on autonomic control of cardiovascular function.
The investigators will determine the effects of hypoglycemia (50 mg/dl for 2. 0 hours) on the
blood inflammatory factor interleukin-6 levels, on cardiovascular autonomic function
(baroreflex sensitivity and heart rate variability) and on arrhythmia risk (microvolt T-wave
alternans (MTWA)) in each subject under two conditions - pretreatment with MR blockade
(eplerenone) and pretreatment with placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy volunteers
- Males and females age 18 to 40 years
Exclusion Criteria:
- Pregnancy
- Lactation
- Menopause
- Any medical condition other than treated hypothyroidism.
- Alcoholism
- Active tobacco use
- In all subjects, any individuals on oral, injected, inhaled or topical
corticosteroids within the last year or oral contraceptives within the past 3 months
will be excluded.
- Use of medications other than physiological thyroxine replacement
- Serum potassium >5. 0 mmol/L
- Estimated GFR < 60 mL/min
Locations and Contacts
Ajaykumar D Rao, MD, Phone: 617-732-8315, Email: adrao@partners.org
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Gail K Adler, MD, PhD, Principal Investigator
Additional Information
Starting date: January 2011
Last updated: September 19, 2012
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