Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eplerenone | Experimental | Eplerenone 50 mg daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone | Drug | 50 mg daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels | 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. | Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial Glucose Serum Levels | 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. | Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gail K Adler, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23006216 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Eplerenone | Eplerenone 50 mg daily for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population included all participants who completed the study and had glucose data available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eplerenone | Eplerenone 50 mg daily for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels | 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. | Data reported for evaluable participants only. All participants who completed the study and had glucose data available. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment |
|
2 weeks
An adverse event (AE) is any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease, whether or not associated with the subject's participation in the research. Unexpected and related/possibly research-related AEs were to be reported to the institutional review board (IRB). Expected AEs (documented in the protocol), were not reported to the IRB.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eplerenone | Eplerenone 50 mg daily for 14 days | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail K Adler | Brigham and Women's Hospital | 617-732-5661 | gadler@partners.org |
Not provided
| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Post-prandial Insulin Serum Levels | 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. | Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Post-prandial Glucose Serum Levels | 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. | Data reported for evaluable participants only. All participants who completed the study and had glucose data available. | Posted | Mean | Standard Deviation | mg/dl | Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment |
|
|
|
| Secondary | Post-prandial Insulin Serum Levels | 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. | Data reported for evaluable participants only. All participants who completed the study and had glucose data available. | Posted | Mean | Standard Deviation | uU/ml | Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment |
|
|
|
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
Not provided
Not provided
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Post-eplerenone, baseline |
|
| Post-eplerenone, 2 hours |
|
| Post-eplerenone, 4 hours |
|
|
| Pre-eplerenone, 4 hours |
|
|
| Post-eplerenone, baseline |
|
|
| Post-eplerenone, 2 hours |
|
|
| Post-eplerenone, 4 hours |
|
|