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NCT01786551 · ClinicalTrials.gov registry record · NA
Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT01786551 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants.
The verdict
NCT01786551, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study 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).
Interventions
- DRUG Eplerenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01786551
The ClinicalTrials.gov registry entry for NCT01786551 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Eplerenone is the first listed.
NCT01786551 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01786551 about?
NCT01786551 is a clinical study titled "Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults". 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,...
What is the current status of trial NCT01786551?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2010-03. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01786551?
The interventions under investigation include: Eplerenone (DRUG).
Who is sponsoring clinical trial NCT01786551?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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