NCT01394627

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

October 1, 2017

Enrollment Period

5.6 years

First QC Date

July 11, 2011

Results QC Date

July 14, 2017

Last Update Submit

October 16, 2017

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Cardiovascular Autonomic Function

    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)

    Baseline and 2 hours after hypoglycemia

Secondary Outcomes (1)

  • Change From Baseline in Inflammation

    Baseline and 2 hours after hypoglycemia

Study Arms (2)

Eplerenone

EXPERIMENTAL

hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose)

Drug: Eplerenone

placebo

PLACEBO COMPARATOR

hypoglycemia of 50 mg/dl plus placebo

Drug: Placebo

Interventions

EplerenoneDRUG

100mg x 2

Eplerenone
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Males and females age 18 to 40 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Rao AD, Bonyhay I, Dankwa J, Baimas-George M, Kneen L, Ballatori S, Freeman R, Adler GK. Baroreflex Sensitivity Impairment During Hypoglycemia: Implications for Cardiovascular Control. Diabetes. 2016 Jan;65(1):209-15. doi: 10.2337/db15-0871. Epub 2015 Oct 5.

    PMID: 26438610RESULT

MeSH Terms

Conditions

Hypoglycemia

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Gail Adler
Organization
Brigham and Women's Hospital
gadler@partners.org
617-732-5661

Study Officials

  • Gail K Adler, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Gail K Adler, MD, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 14, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 17, 2017

Results First Posted

November 17, 2017

Record last verified: 2017-10

Locations

US(1)