We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01786551
First Posted: February 8, 2013
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gail Kurr Adler, Brigham and Women's Hospital
  Purpose

The purpose of this study is to investigate the effect of mineralocorticoid receptor (MR) blockade in healthy participants in a systemic proinflammatory state after a meal high in fat and glucose, which is associated with the pathogenesis of atherosclerosis.

Participants will include normal-weight, healthy males (Body Mass Index (BMI) ≤ 25 kg/m^2) between the ages of 18-45, without hypertension and clinical evidence of metabolic, cardiovascular or any other kind of diseases. After a 12-hour (h) fast, participants 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, participants 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 will measure a parameter of vascular and systemic inflammation: interleukin-6 (IL-6).


Condition Intervention
Systemic Proinflammatory State Drug: Eplerenone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Gail Kurr Adler, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ]
    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.


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

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


Enrollment: 16
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 for 14 days
Drug: Eplerenone
50 mg daily for 14 days

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male
  • 18-45 years
  • BMI between 20-25 kg/m^2

Exclusion Criteria:

  • evidence of cardiovascular, hepatic, renal [estimated glomerular filtration rate (GFR) <60 millimeter/minute (ml/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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Gail Kurr Adler, Associate Professor, 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
Last Verified: April 2017

Additional relevant MeSH terms:
Eplerenone
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents