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
  Purpose

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


Condition Intervention
Systemic Proinflammatory State
Drug: Eplerenone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Vascular and systemic inflammation: IL-6 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: March 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eplerenone
eplerenone 50 mg daily
Drug: Eplerenone
50mg daily

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786551

Locations
United States, Massachusetts
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
  More Information

No publications provided

Responsible Party: Gail Kurr Adler, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01786551     History of Changes
Other Study ID Numbers: 2010P002191
Study First Received: February 4, 2013
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014