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Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
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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 |
- 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.
- 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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01786551
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| 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 |
| Study First Received: | February 4, 2013 |
| Results First Received: | April 11, 2017 |
| Last Updated: | April 11, 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 |
ClinicalTrials.gov processed this record on August 23, 2017