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Hypoglycemia and the Mineralocorticoid Receptor (HypoMR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Gail Kurr Adler, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01394627
First received: July 11, 2011
Last updated: July 15, 2014
Last verified: July 2014
  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. 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 Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Hypoglycemia and the Mineralocorticoid Receptor

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change from Baseline in Cardiovascular Autonomic Function [ Time Frame: Baseline and 2 hours after hypoglycemia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Inflammation [ Time Frame: Baseline and 2 hours after hypoglycemia ] [ Designated as safety issue: No ]
  • Change from Baseline in fMRI [ Time Frame: Baseline and after exposure to hypoglycemia ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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 GFR < 60 mL/min
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394627

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

Locations
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
Investigators
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

No publications provided

Responsible Party: Gail Kurr Adler, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01394627     History of Changes
Other Study ID Numbers: 2010P002054
Study First Received: July 11, 2011
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014