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Completed

NCT Number: NCT01786551

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).

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Key information

Conditions

Systemic Proinflammatory State

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eplerenone

Drug

50 mg daily for 14 days

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 8, 2013
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.