N/A
N=16
Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
Systemic Proinflammatory State
Bottom Line
View on ClinicalTrials.gov: NCT01786551 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels — 1.70; 1.51; 1.65; 1.78 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Eplerenone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels |
1.70; 1.51; 1.65; 1.78; 1.47; 1.75 | — |
| SECONDARY Post-prandial Glucose Serum Levels |
91; 105; 93; 89; 102; 92 | — |
| SECONDARY Post-prandial Insulin Serum Levels |
4.5; 33.0; 10.4; 5.7; 23.2; 8.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01786551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.