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临床试验/NCT01786551
NCT01786551已完成不适用

Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gail Kurr Adler

Associate Professor

Brigham and Women's Hospital

研究点 (1)

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