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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014