Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 78 of 112 for:    EPLERENONE

Hypoglycemia and the Mineralocorticoid Receptor (HypoMR)

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.
 
ClinicalTrials.gov Identifier: NCT01394627
Recruitment Status : Completed
First Posted : July 14, 2011
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Hypoglycemia
Interventions Drug: Eplerenone
Drug: Placebo
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo (Period 1) /Washout (Period 2)/Eplerenone (Period 3) Eplerenone (Period 1) /Washout (Period 2)/Placebo (Period 3)
Hide Arm/Group Description

hypoglycemia of 50 mg/dl with 1 day of placebo pretreatment

then after 1-3 month washout

hypoglycemia of 50 mg/dl with 1 day of eplerenone (100 mg x 2) pretreatment

hypoglycemia of 50 mg/dl with 1 day of eplerenone (100 mg x 2) pretreatment

then after 1-3 month washout

hypoglycemia of 50 mg/dl with 1 day of placebo pretreatment

Period Title: First Intervention (1 Day)
Started 8 13
Completed 8 12
Not Completed 0 1
Reason Not Completed
poor intravenous access             0             1
Period Title: Washout (1-3 Months)
Started 8 12
Completed 7 12
Not Completed 1 0
Reason Not Completed
concurrent enrollment in another study             1             0
Period Title: Second Intervention (1 Day)
Started 7 12
Completed 7 12
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
26.5  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
5
  23.8%
Male
16
  76.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Hispanic or Latino
1
   4.8%
Not Hispanic or Latino
19
  90.5%
Unknown or Not Reported
1
   4.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  19.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  19.0%
White
12
  57.1%
More than one race
1
   4.8%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
 100.0%
1.Primary Outcome
Title Change From Baseline in Cardiovascular Autonomic Function
Hide Description 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)
Time Frame Baseline and 2 hours after hypoglycemia
Hide Outcome Measure Data
Hide Analysis Population Description
We included the 13 subjects who completed each arm, had usable baroreflex sensitivity data for both treatments (placebo and eplerenone), and achieved a blood sugar during hypoglycemia of less than or equal to 3.0 mmol/L for each clamp.
Arm/Group Title Eplerenone Placebo
Hide Arm/Group Description:

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

Eplerenone: 100mg x 2

hypoglycemia of 50 mg/dl plus placebo

Placebo

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
-16.00  (18.39) -16.59  (16.77)
2.Secondary Outcome
Title Change From Baseline in Inflammation
Hide Description Change in interleukin-6
Time Frame Baseline and 2 hours after hypoglycemia
Hide Outcome Measure Data
Hide Analysis Population Description
We included the 17 subjects who completed each arm and had interleukin-6 data for both arms (placebo and eplerenone). We calculated the change in IL-6 as IL-6 during hypoglycemia minus IL-6 at baseline.
Arm/Group Title Eplerenone Placebo
Hide Arm/Group Description:

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

Eplerenone: 100mg x 2

hypoglycemia of 50 mg/dl plus placebo

Placebo

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: pg/ml
2.03  (1.27) 2.61  (2.63)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eplerenone Placebo
Hide Arm/Group Description hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose) Eplerenone: 100mg x 2 hypoglycemia of 50 mg/dl plus placebo Placebo
All-Cause Mortality
Eplerenone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Eplerenone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eplerenone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gail Adler
Organization: Brigham and Women's Hospital
Phone: 617-732-5661
EMail: gadler@partners.org
Layout table for additonal information
Responsible Party: Gail Kurr Adler, 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 17, 2017
Last Update Posted: November 17, 2017