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Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gail Kurr Adler, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01786551
First received: February 4, 2013
Last updated: April 11, 2017
Last verified: April 2017
February 4, 2013
April 11, 2017
March 2010
January 2013   (Final data collection date for primary outcome measure)
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.
Vascular and systemic inflammation: IL-6 [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT01786551 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
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, 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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Systemic Proinflammatory State
Drug: Eplerenone
50 mg daily for 14 days
Experimental: Eplerenone
Eplerenone 50 mg daily for 14 days
Intervention: Drug: Eplerenone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01786551
2010P002191
No
Not Provided
Not Provided
Gail Kurr Adler, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Gail K Adler, MD, PhD Brigham and Women's Hospital
Brigham and Women's Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP