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Hypoglycemia and the Mineralocorticoid Receptor (HypoMR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Gail Kurr Adler, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: July 14, 2011
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Gail Kurr Adler, Brigham and Women's Hospital
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. We are also looking at the effect of hypoglycemia on fMRI.

Condition Intervention
Hypoglycemia Drug: Eplerenone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Hypoglycemia and the Mineralocorticoid Receptor

Resource links provided by NLM:

Further study details as provided by Gail Kurr Adler, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change from Baseline in Cardiovascular Autonomic Function [ Time Frame: Baseline and 2 hours after hypoglycemia ]

Secondary Outcome Measures:
  • Change from Baseline in Inflammation [ Time Frame: Baseline and 2 hours after hypoglycemia ]
  • Change from Baseline in fMRI [ Time Frame: Baseline and after exposure to hypoglycemia ]

Estimated Enrollment: 25
Study Start Date: January 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eplerenone
hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose)
Drug: Eplerenone
100mg x 2
Placebo Comparator: placebo
hypoglycemia of 50 mg/dl plus placebo

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 Aims:

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.

To investigate the role of hypoglycemia on fMRI.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394627

Contact: Ajaykumar D Rao, MD 617-732-8315 adrao@partners.org

United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Gail K Adler, MD, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Robert Wood Johnson Foundation
Study Chair: Ajaykumar D Rao, MD Brigham and Women's Hospital
Principal Investigator: Gail K Adler, MD, PhD Brigham and Women's Hospital
  More Information

Responsible Party: Gail Kurr Adler, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01394627     History of Changes
Other Study ID Numbers: 2010P002054
First Submitted: July 11, 2011
First Posted: July 14, 2011
Last Update Posted: October 17, 2017
Last Verified: July 2015

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents