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: August 27, 2013
Last verified: August 2013

February 4, 2013
August 27, 2013
March 2010
January 2013   (final data collection date for primary outcome measure)
Vascular and systemic inflammation: IL-6 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01786551 on ClinicalTrials.gov Archive Site
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Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
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The purpose of this project is to investigate the effect of mineralocorticoid receptor (MR) blockade in healthy subjects on the systemic proinflammatory state after a meal high in fat and glucose.

Subjects will include normal weight, healthy male subjects (BMI ≤ 25 kg/m2) between the age of 18-45, without hypertension and clinical evidence of metabolic, cardiovascular or any other kind of diseases. After a 12h fast, subjects 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, subjects 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 measure a parameter of vascular and systemic inflammation: IL-6

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Systemic Proinflammatory State
Drug: Eplerenone
50mg daily
Experimental: eplerenone
eplerenone 50 mg daily
Intervention: Drug: Eplerenone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male
  • 18-45 years
  • BMI between 20-25 kg/m2

Exclusion Criteria:

  • evidence of cardiovascular, hepatic, renal (estimated GFR <60ml/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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01786551
2010P002191
No
Gail Kurr Adler, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Gail K Adler, MD, PhD Brigham and Women's Hospital
Brigham and Women's Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP