Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
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| ClinicalTrials.gov Identifier: NCT01786551 |
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Recruitment Status
:
Completed
First Posted
: February 8, 2013
Results First Posted
: May 17, 2017
Last Update Posted
: May 17, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Systemic Proinflammatory State | Drug: Eplerenone | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults |
| Study Start Date : | March 2010 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Eplerenone
Eplerenone 50 mg daily for 14 days
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Drug: Eplerenone
50 mg daily for 14 days
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- 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.
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| 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
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
| 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 |
Publications of Results:
| 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 Posted: | February 8, 2013 Key Record Dates |
| Results First Posted: | May 17, 2017 |
| Last Update Posted: | May 17, 2017 |
| Last Verified: | April 2017 |
Additional relevant MeSH terms:
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Eplerenone Spironolactone Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents |