Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-45 years
- •BMI between 20-25 kg/m^2
排除标准
- •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
- •alcohol consumption of more than 2 drinks per day
- •dietary supplements
研究组 & 干预措施
Eplerenone
Eplerenone 50 mg daily for 14 days
干预措施: Eplerenone (Drug)
结局指标
主要结局
Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels
时间窗: 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.
次要结局
- Post-prandial Glucose Serum Levels(Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment)
- Post-prandial Insulin Serum Levels(Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment)
研究者
Gail Kurr Adler
Associate Professor
Brigham and Women's Hospital
