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Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gail Kurr Adler, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01786551
First received: February 4, 2013
Last updated: April 11, 2017
Last verified: April 2017
Results First Received: April 11, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Systemic Proinflammatory State
Intervention: Drug: Eplerenone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Eplerenone Eplerenone 50 mg daily for 14 days

Participant Flow:   Overall Study
    Eplerenone
STARTED   16 
COMPLETED   14 
NOT COMPLETED   2 
Participant withdrew consent                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline analysis population included all participants who completed the study and had glucose data available.

Reporting Groups
  Description
Eplerenone Eplerenone 50 mg daily for 14 days

Baseline Measures
   Eplerenone 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Mean (Standard Deviation)
 25  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      13 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures
  Show All Outcome Measures

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gail K Adler
Organization: Brigham and Women's Hospital
phone: 617-732-5661
e-mail: gadler@partners.org


Publications of Results:

Responsible Party: Gail Kurr Adler, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01786551     History of Changes
Other Study ID Numbers: 2010P002191
Study First Received: February 4, 2013
Results First Received: April 11, 2017
Last Updated: April 11, 2017