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临床试验/NCT04140045
NCT04140045已完成不适用

The Effect of Hypohydration During Cycling in the Heat on Acute Kidney Injury Biomarkers

Loughborough University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values)

研究概览

简要总结

Acute Kidney Injury (AKI) is common in prolonged endurance events. Risk factors for exercise-associated AKI include: the exercise itself, heat, hypohydration, muscle breakdown and non-steroidal anti-inflammatory drug (NSAID) use. Prior research from our laboratory showed the hypohydration during high-intensity running increased a biomarker of AKI (urine osmolality-corrected kidney injury molecule 1). Therefore, the current study will now investigate the effect of manipulating hydration status during cycling on biomarkers of AKI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • recreationally active

排除标准

  • Smoker/vaper
  • regular use of anti-inflammatory medications (e.g. ibuprofen)
  • history of kidney disease or diabetes

结局指标

主要结局

Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values)

时间窗: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline

A novel protein biomarker for acute kidney injury

Changes in serum creatinine

时间窗: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline

Serum creatinine is a marker of kidney function

Changes in urinary Kidney Injury Molecule 1 (uKIM-1) (uncorrected/raw values and urine osmolality-corrected values)

时间窗: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline

A novel protein biomarker for acute kidney injury

Changes in urine osmolality

时间窗: Pre-exercise (baseline) and post-exercise (immediately after the intervention), as well as all urine produced from post-exercise until 24 hours post-baseline

A measure of urine concentration.

Incidence of Acute Kidney Injury (as determined by changes in serum creatinine)

时间窗: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline

A rise in serum creatinine of 1.5 fold or more from baseline will be defined as acute kidney injury

次要结局

  • Changes in thermal comfort scores(pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Changes in creatine kinase(Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline)
  • Changes in nausea scores(pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Changes in stomach fullness scores(pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Plasma volume changes(Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline)
  • Body mass changes(pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline)
  • Changes in thirst scores(pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Changes in stomach bloatedness scores(pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Changes in serum osmolality(Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline)
  • Changes in lactate dehydrogenase(Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline)
  • Ad libitum energy (Kj), carbohydrate (g), sugar (g), protein (g), fat (g), saturated fat (g), sodium (g) and water intake (g).(from post-exercise (immediately after the intervention) until 24 hours post-baseline)
  • Changes in headache scores(pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Changes in dizziness scores(pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Changes in gastrointestinal comfort scores(pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Changes in urge to vomit scores(pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Changes in urinary creatinine(pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline)
  • Changes in heart rate(Will be monitored throughout the exercise intervention, at 15 minute intervals (15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes and 120 minutes))
  • changes in rating of perceived exertion(Will be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes))
  • Changes in aural temperature(Will be determined immediately prior to the exercise intervention (at rest) and then throughout the exercise intervention at 15 minute intervals (15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes and 120 minutes))

研究者

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

Loris Juett

Principal Investigator

Loughborough University

研究点 (2)

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