Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01786551
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 34.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of mineralocorticoid receptor (MR) blockade in healthy participants in a systemic proinflammatory state after a meal high in fat and glucose, which is associated with the pathogenesis of atherosclerosis.

Participants will include normal-weight, healthy males (Body Mass Index (BMI) ≤ 25 kg/m^2) between the ages of 18-45, without hypertension and clinical evidence of metabolic, cardiovascular or any other kind of diseases. After a 12-hour (h) fast, participants will be assigned to a combination of oral fat-loading test (OFLT) and oral glucose tolerance test (OGTT) (day 1), followed by a two-week treatment with 50 mg eplerenone. After two weeks, participants will receive the second OFLT/OGTT treatment (day 15). Starting 5 days prior to the first intervention (day1), the participant's usual diet (ad lib) will be supplemented with 2 bullion broths each day. Standardization of sodium intake is necessary as variations in dietary sodium intake may affect outcome measures. We will evaluate the following parameters at day 1 and day 15 of the study. Prior to OFLT/OGTT, and 2h, 4h thereafter, we will measure a parameter of vascular and systemic inflammation: interleukin-6 (IL-6).

Condition or Disease	Intervention/Treatment	Phase
Systemic Proinflammatory State	Drug: Eplerenone	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eplerenone Eplerenone 50 mg daily for 14 days	Drug: Eplerenone; 50 mg daily for 14 days

Outcome Measures

Primary Outcome Measures

1. Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels [Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment]

   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.

Secondary Outcome Measures

1. Post-prandial Glucose Serum Levels [Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment]

   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.

2. Post-prandial Insulin Serum Levels [Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• male

• 18-45 years

• BMI between 20-25 kg/m^2

Exclusion Criteria:

• evidence of cardiovascular, hepatic, renal [estimated glomerular filtration rate (GFR) <60 millimeter/minute (ml/min)] or any other organ system disease

• Blood pressure equal to or less than 90/60 mmHg

• prescription or herbal medications

• smoking

• alcohol consumption of more than 2 drinks per day

• dietary supplements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Gail K Adler, MD, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gail Kurr Adler, Associate Professor, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01786551
• Other Study ID Numbers: 2010P002191
• First Posted: Feb 8, 2013
• Last Update Posted: May 17, 2017
• Last Verified: Apr 1, 2017

• Additional relevant MeSH terms: Eplerenone

Study Results

Participant Flow

Arm/Group Title	Eplerenone
Arm/Group Description	Eplerenone 50 mg daily for 14 days
Period Title: Overall Study
STARTED	16
COMPLETED	14
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Eplerenone
Arm/Group Description	Eplerenone 50 mg daily for 14 days
Overall Participants	13
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25 (8)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	13 100%
Region of Enrollment (participants) [Number]
United States	13 100%

Outcome Measures

1. Primary Outcome

Title	Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels
Description	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.
Time Frame	Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Eplerenone
Arm/Group Description	Eplerenone 50 mg daily for 14 days
Measure Participants	13
Pre-eplerenone, baseline	1.70 (0.93)
Pre-eplerenone, 2 hours	1.51 (0.73)
Pre-eplerenone, 4 hours	1.65 (0.79)
Post-eplerenone, baseline	1.78 (0.85)
Post-eplerenone, 2 hours	1.47 (0.93)
Post-eplerenone, 4 hours	1.75 (0.96)

2. Secondary Outcome

Title	Post-prandial Glucose Serum Levels
Description	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.
Time Frame	Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Eplerenone
Arm/Group Description	Eplerenone 50 mg daily for 14 days
Measure Participants	13
Pre-eplerenone, baseline	91 (7)
Pre-eplerenone, 2 hours	105 (28)
Pre-eplerenone, 4 hours	93 (17)
Post-eplerenone, baseline	89 (12)
Post-eplerenone, 2 hours	102 (21)
Post-eplerenone, 4 hours	92 (20)

3. Secondary Outcome

Title	Post-prandial Insulin Serum Levels
Description	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.
Time Frame	Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Eplerenone
Arm/Group Description	Eplerenone 50 mg daily for 14 days
Measure Participants	13
Pre-eplerenone, baseline	4.5 (3.6)
Pre-eplerenone, 2 hours	33.0 (45.7)
Pre-eplerenone, 4 hours	10.4 (10.7)
Post-eplerenone, baseline	5.7 (8.7)
Post-eplerenone, 2 hours	23.2 (21.5)
Post-eplerenone, 4 hours	8.7 (6.2)

Adverse Events

Time Frame	2 weeks
Adverse Event Reporting Description	An adverse event (AE) is any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease, whether or not associated with the subject's participation in the research. Unexpected and related/possibly research-related AEs were to be reported to the institutional review board (IRB). Expected AEs (documented in the protocol), were not reported to the IRB.
Arm/Group Title	Eplerenone
Arm/Group Description	Eplerenone 50 mg daily for 14 days
All Cause Mortality
	Eplerenone
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Serious Adverse Events
	Eplerenone
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	Eplerenone
	Affected / at Risk (%)	# Events
Total	0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.