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Trial record 12 of 112 for:    EPLERENONE

Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

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ClinicalTrials.gov Identifier: NCT01786551
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Gail Kurr Adler, Brigham and Women's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Systemic Proinflammatory State
Intervention Drug: Eplerenone
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eplerenone
Hide Arm/Group Description Eplerenone 50 mg daily for 14 days
Period Title: Overall Study
Started 16
Completed 14
Not Completed 2
Reason Not Completed
Participant withdrew consent             2
Arm/Group Title Eplerenone
Hide Arm/Group Description Eplerenone 50 mg daily for 14 days
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
The baseline analysis population included all participants who completed the study and had glucose data available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
25  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
0
   0.0%
Male
13
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data reported for evaluable participants only. All participants who completed the study and had glucose data available.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Eplerenone 50 mg daily for 14 days
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
Pre-eplerenone, baseline Number Analyzed 11 participants
1.70  (0.93)
Pre-eplerenone, 2 hours Number Analyzed 10 participants
1.51  (0.73)
Pre-eplerenone, 4 hours Number Analyzed 12 participants
1.65  (0.79)
Post-eplerenone, baseline Number Analyzed 11 participants
1.78  (0.85)
Post-eplerenone, 2 hours Number Analyzed 9 participants
1.47  (0.93)
Post-eplerenone, 4 hours Number Analyzed 12 participants
1.75  (0.96)
2.Secondary Outcome
Title Post-prandial Glucose Serum Levels
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data reported for evaluable participants only. All participants who completed the study and had glucose data available.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Eplerenone 50 mg daily for 14 days
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mg/dl
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data reported for evaluable participants only. All participants who completed the study and had glucose data available.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Eplerenone 50 mg daily for 14 days
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: uU/ml
Pre-eplerenone, baseline Number Analyzed 13 participants
4.5  (3.6)
Pre-eplerenone, 2 hours Number Analyzed 13 participants
33.0  (45.7)
Pre-eplerenone, 4 hours Number Analyzed 13 participants
10.4  (10.7)
Post-eplerenone, baseline Number Analyzed 13 participants
5.7  (8.7)
Post-eplerenone, 2 hours Number Analyzed 11 participants
23.2  (21.5)
Post-eplerenone, 4 hours Number Analyzed 12 participants
8.7  (6.2)
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
Hide Arm/Group Description Eplerenone 50 mg daily for 14 days
All-Cause Mortality
Eplerenone
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Eplerenone
Affected / at Risk (%)
Total   0/16 (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
Affected / at Risk (%)
Total   0/16 (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 K 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: NCT01786551     History of Changes
Other Study ID Numbers: 2010P002191
First Submitted: February 4, 2013
First Posted: February 8, 2013
Results First Submitted: April 11, 2017
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017