Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (IGFBP7xTIMP2)
研究概览
简要总结
The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at moderate intensity. Urine, plasma, and serum samples were collected pre-, post-, and 1hour post-exercise to assess biomarkers of acute kidney injury. This was a double blind, randomized crossover design, so that participants completed the alternate trial (ibuprofen or placebo) at least seven days later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physically active (engage in at least 150 minutes of moderate to vigorous intensity exercise per week)
- •between the ages of 18 and 45
- •Able to run continuously for at least 60 minutes
- •Able to speak and read English.
排除标准
- •Non-English speakers, prisoners, pregnant women, or persons requiring a LAR
- •Previous history of heat stroke or heat illness
- •Currently experiencing a sunburn or other burn injury
- •Have repeated exposure to heat, such as hot baths, sauna, or travel to a hot environment
- •Has resided in a hot climate within 2 months prior to the trial
- •Answered "yes" to at least one question on the physical activity readiness questionnaire
- •Shows signs or symptoms of or are known to have cardiovascular, renal, metabolic, or pulmonary disease as determined by a health questionnaire
- •Are a current smoker
- •History of regular gastrointestinal distress
- •Known history of stomach ulcers or taking blood thinning medication
- •Known allergy to ibuprofen
- •Have a resting blood pressure greater than 140 systolic or 90 diastolic
- •Do not engage in at least 150 minutes of moderate to vigorous intensity exercise per week.
研究组 & 干预措施
Placebo (Corn Starch)
600 mg of corn starch was ingested 12- and 1-hour prior to exercise.
干预措施: Placebo Corn Starch (Drug)
Ibuprofen
600 mg of Ibuprofen was ingested 12- and 1-hour prior to exercise.
干预措施: Ibuprofen 600 mg (Drug)
结局指标
主要结局
Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (IGFBP7xTIMP2)
时间窗: Change in urinary IGFBP7xTIMP2 pre-exercise and 1 hour post-exercise.
The product of urinary IGFBP7 and urinary TIMP2 (IGFBP7xTIMP2) will be measured at all time points.
Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (Urinary NGAL)
时间窗: Change in urinary NGAL pre-exercise and peak post-exercise.
Urinary NGAL will be measured at all time points.
Biomarker of glomerular filtration rate from Ibuprofen Ingestion Prior to Exercise in the Heat (Serum cystatin C)
时间窗: Change in serum cystatin C pre-exercise and 1 hour post-exercise.
Serum cystatin C will be measured at all time points.
次要结局
- Circulating Marker of Intestinal Injury from Ibuprofen Ingestion Prior to Exercise in the Heat(Change in plasma I-FABP from pre- to immediately 1 hour post-exercise.)
- Circulating Marker of Intestinal Permeability from Ibuprofen Ingestion Prior to Exercise in the Heat(Change in plasma LBP from pre- to immediately 1 hour post-exercise.)
- Circulating Marker of Endotoxemia from Ibuprofen Ingestion Prior to Exercise in the Heat(Change in plasma sCD14 from pre- to immediately 1 hour post-exercise.)