Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

NCT01786551 | Completed Results

• 1 other identifier: 2010P002191
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Systemic Proinflammatory State

Outcome Measures

Primary Outcomes (1)

• Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels

  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.

  Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

Secondary Outcomes (2)

• Post-prandial Glucose Serum Levels

  Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

• Post-prandial Insulin Serum Levels

  Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment

Study Arms (1)

Eplerenone

EXPERIMENTAL

Eplerenone 50 mg daily for 14 days

Drug: Eplerenone

Interventions

Eplerenone DRUG

50 mg daily for 14 days

Eplerenone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Krug AW, Stelzner L, Rao AD, Lichtman AH, Williams GH, Adler GK. Effect of low dose mineralocorticoid receptor antagonist eplerenone on glucose and lipid metabolism in healthy adult males. Metabolism. 2013 Mar;62(3):386-91. doi: 10.1016/j.metabol.2012.08.011. Epub 2012 Sep 21.

  PMID: 23006216 RESULT

MeSH Terms

Interventions

Eplerenone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Gail K Adler
• Organization: Brigham and Women's Hospital

gadler@partners.org

617-732-5661

Study Officials

• Gail K Adler, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 8, 2013
• Study Start: March 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 17, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-04

Locations

US (1)