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Hypoglycemia and the Mineralocorticoid Receptor (HypoMR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394627
First Posted: July 14, 2011
Last Update Posted: November 16, 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.
Collaborators:
Robert Wood Johnson Foundation
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Gail Kurr Adler, Brigham and Women's Hospital
  Purpose
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.

Condition Intervention
Hypoglycemia Drug: Eplerenone Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 ]
    Modified oxford procedures was performed in duplicate immediately prior to start of the hypoglycemic clamp and during the last 30 min of the clamp (i.e. during the last 30 min of exposure to 2 hours of hypoglycemia).. We calculated the baroreflex sensitivity (the relationship between RR interval and change in systolic blood pressure defined as the change in the inter-beat cardiac interval in milliseconds per unit change in blood pressure in mmHg) at each time point and then the change in baroreflex sensitivity (BRS during hypoglycemia minus BRS at baseline)


Secondary Outcome Measures:
  • Change From Baseline in Inflammation [ Time Frame: Baseline and 2 hours after hypoglycemia ]
    Change in interleukin-6


Enrollment: 21
Study Start Date: January 2011
Study Completion Date: August 2016
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
Drug: 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, and on cardiovascular autonomic function (baroreflex sensitivity) in each subject under two conditions - pretreatment with MR blockade (eplerenone) and pretreatment with placebo.

  Eligibility

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Robert Wood Johnson Foundation
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Gail K Adler, MD Brigham and Women's Hospital
Principal Investigator: Gail K Adler, MD, PhD Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Gail Kurr Adler, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01394627     History of Changes
Other Study ID Numbers: 2010P002054
K24HL103845 ( U.S. NIH Grant/Contract )
R01HL109634 ( U.S. NIH Grant/Contract )
T32HL007609 ( U.S. NIH Grant/Contract )
First Submitted: July 11, 2011
First Posted: July 14, 2011
Results First Submitted: July 14, 2017
Results First Posted: November 16, 2017
Last Update Posted: November 16, 2017
Last Verified: October 2017

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