Clinical trial NCT01786551: Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
Official title: Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Proinflammatory State
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


Eligibility 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

Primary outcomes:
measure: Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels
timeFrame: Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment
Secondary outcomes:
measure: Post-prandial Glucose Serum Levels
timeFrame: Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment
measure: Post-prandial Insulin Serum Levels
timeFrame: Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Gail K Adler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.