Trial Outcomes & Findings for Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults (NCT NCT01786551)

Results Overview

At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

Results posted on

2017-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	Eplerenone Eplerenone 50 mg daily for 14 days
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Eplerenone Eplerenone 50 mg daily for 14 days
Overall Study Participant withdrew consent	2

Baseline Characteristics

Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eplerenone n=13 Participants Eplerenone 50 mg daily for 14 days
Age, Continuous	25 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

Population: Data reported for evaluable participants only. All participants who completed the study and had glucose data available.

At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.

Outcome measures

Outcome measures
Measure	Eplerenone n=13 Participants Eplerenone 50 mg daily for 14 days
Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels Pre-eplerenone, baseline	1.70 ng/mL Standard Deviation 0.93
Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels Pre-eplerenone, 2 hours	1.51 ng/mL Standard Deviation 0.73
Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels Pre-eplerenone, 4 hours	1.65 ng/mL Standard Deviation 0.79
Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels Post-eplerenone, baseline	1.78 ng/mL Standard Deviation 0.85
Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels Post-eplerenone, 2 hours	1.47 ng/mL Standard Deviation 0.93
Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels Post-eplerenone, 4 hours	1.75 ng/mL Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

Population: Data reported for evaluable participants only. All participants who completed the study and had glucose data available.

At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.

Outcome measures

Outcome measures
Measure	Eplerenone n=13 Participants Eplerenone 50 mg daily for 14 days
Post-prandial Glucose Serum Levels Pre-eplerenone, baseline	91 mg/dl Standard Deviation 7
Post-prandial Glucose Serum Levels Pre-eplerenone, 2 hours	105 mg/dl Standard Deviation 28
Post-prandial Glucose Serum Levels Pre-eplerenone, 4 hours	93 mg/dl Standard Deviation 17
Post-prandial Glucose Serum Levels Post-eplerenone, baseline	89 mg/dl Standard Deviation 12
Post-prandial Glucose Serum Levels Post-eplerenone, 2 hours	102 mg/dl Standard Deviation 21
Post-prandial Glucose Serum Levels Post-eplerenone, 4 hours	92 mg/dl Standard Deviation 20

SECONDARY outcome

Timeframe: Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

Population: Data reported for evaluable participants only. All participants who completed the study and had glucose data available.

At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.

Outcome measures

Outcome measures
Measure	Eplerenone n=13 Participants Eplerenone 50 mg daily for 14 days
Post-prandial Insulin Serum Levels Pre-eplerenone, baseline	4.5 uU/ml Standard Deviation 3.6
Post-prandial Insulin Serum Levels Pre-eplerenone, 2 hours	33.0 uU/ml Standard Deviation 45.7
Post-prandial Insulin Serum Levels Pre-eplerenone, 4 hours	10.4 uU/ml Standard Deviation 10.7
Post-prandial Insulin Serum Levels Post-eplerenone, baseline	5.7 uU/ml Standard Deviation 8.7
Post-prandial Insulin Serum Levels Post-eplerenone, 2 hours	23.2 uU/ml Standard Deviation 21.5
Post-prandial Insulin Serum Levels Post-eplerenone, 4 hours	8.7 uU/ml Standard Deviation 6.2

Adverse Events

Eplerenone

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 K 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