Trial Outcomes & Findings for Hypoglycemia and the Mineralocorticoid Receptor (NCT NCT01394627)

Last Updated: 2017-11-17

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

Baseline and 2 hours after hypoglycemia

Results posted on

2017-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo (Period 1) /Washout (Period 2)/Eplerenone (Period 3) 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	Eplerenone (Period 1) /Washout (Period 2)/Placebo (Period 3) 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
First Intervention (1 Day) STARTED	8	13
First Intervention (1 Day) COMPLETED	8	12
First Intervention (1 Day) NOT COMPLETED	0	1
Washout (1-3 Months) STARTED	8	12
Washout (1-3 Months) COMPLETED	7	12
Washout (1-3 Months) NOT COMPLETED	1	0
Second Intervention (1 Day) STARTED	7	12
Second Intervention (1 Day) COMPLETED	7	12
Second Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (Period 1) /Washout (Period 2)/Eplerenone (Period 3) 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	Eplerenone (Period 1) /Washout (Period 2)/Placebo (Period 3) 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
First Intervention (1 Day) poor intravenous access	0	1
Washout (1-3 Months) concurrent enrollment in another study	1	0

Baseline Characteristics

Hypoglycemia and the Mineralocorticoid Receptor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=21 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	26.5 years STANDARD_DEVIATION 5.6 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	21 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 2 hours after hypoglycemia

Population: 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.

Outcome measures

Outcome measures
Measure	Eplerenone n=13 Participants hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose) Eplerenone: 100mg x 2	Placebo n=13 Participants hypoglycemia of 50 mg/dl plus placebo Placebo
Change From Baseline in Cardiovascular Autonomic Function	-16.00 ms/mmHg Standard Deviation 18.39	-16.59 ms/mmHg Standard Deviation 16.77

SECONDARY outcome

Timeframe: Baseline and 2 hours after hypoglycemia

Population: 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.

Change in interleukin-6

Outcome measures

Outcome measures
Measure	Eplerenone n=17 Participants hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose) Eplerenone: 100mg x 2	Placebo n=17 Participants hypoglycemia of 50 mg/dl plus placebo Placebo
Change From Baseline in Inflammation	2.03 pg/ml Standard Deviation 1.27	2.61 pg/ml Standard Deviation 2.63

Adverse Events

Eplerenone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gail Adler

Brigham and Women's Hospital

Phone: 617-732-5661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place