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临床试验/NCT04767347
NCT04767347已完成不适用

Renal Considerations in the Heat Stress Recommendations

Indiana University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Peak urinary [IGFBP7•TIMP-2]

研究概览

简要总结

An epidemic of chronic kidney disease is occurring in laborers who undertake physical work outdoors in hot conditions. The reason for this is unknown, but may be related to kidney dysfunction caused by increases in body temperature and dehydration. The current heat stress recommendations for workers were not developed with regards for kidney health. The purpose of this study is to determine if the current recommendations protect against kidney dysfunction.

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, Outcomes Assessor)

盲法说明

The participant will not be directly informed of the experimental conditions and will be blinded to the hypotheses.

The outcomes assessor will be blinded to the experimental conditions when analyzing the data.

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men and women
  • •18-44 y old
  • •Body mass index ≤35.0 kg/m2
  • •Self-reported to be healthy.

排除标准

  • •Not within defined age range
  • •Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
  • •Deemed highly active according to the physical activity questionnaire (i.e., >3500 MET*min/wk)
  • •Body mass index >35.0 kg/m2
  • •Current or history of any renal disease, heart disease, stroke, immune or autoimmune disease, and/or gastrointestinal disease/surgery
  • •Hypertension during screening (systolic blood pressure >139 or diastolic blood pressure >89)
  • •Using medications that blunt the physiological response to exercise (e.g., beta blockers)
  • •Prescription medication with a known side effect of impaired temperature regulation or fluid balance (e.g., diuretics)
  • •Positive pregnancy test at any time during the study or breast feeding
  • •Current tobacco or electronic cigarette use or consistent use within the last 2 years
  • •Inability to safely complete the peak oxygen uptake test

研究组 & 干预措施

Fixed Work Rate

Experimental

Participants will walk on a treadmill at 3 mph and the grade will be adjusted to elicit 430 W of metabolic heat production (the most common work intensity). This study will systematically examine the NIOSH recommendations for prescribing work-to-rest ratios with increasing environmental heat stress (defined as Wet Bulb Globe Temperature, WBGT) at this fixed rate of metabolic heat production on kidney function.

干预措施: 23.0°C WBGT - Fixed Work Rate (Other)

Fixed Work Rate

Experimental

Participants will walk on a treadmill at 3 mph and the grade will be adjusted to elicit 430 W of metabolic heat production (the most common work intensity). This study will systematically examine the NIOSH recommendations for prescribing work-to-rest ratios with increasing environmental heat stress (defined as Wet Bulb Globe Temperature, WBGT) at this fixed rate of metabolic heat production on kidney function.

干预措施: 25.5°C WBGT - Fixed Work Rate (Other)

Fixed Work Rate

Experimental

Participants will walk on a treadmill at 3 mph and the grade will be adjusted to elicit 430 W of metabolic heat production (the most common work intensity). This study will systematically examine the NIOSH recommendations for prescribing work-to-rest ratios with increasing environmental heat stress (defined as Wet Bulb Globe Temperature, WBGT) at this fixed rate of metabolic heat production on kidney function.

干预措施: 27.5°C WBGT - Fixed Work Rate (Other)

Fixed Work Rate

Experimental

Participants will walk on a treadmill at 3 mph and the grade will be adjusted to elicit 430 W of metabolic heat production (the most common work intensity). This study will systematically examine the NIOSH recommendations for prescribing work-to-rest ratios with increasing environmental heat stress (defined as Wet Bulb Globe Temperature, WBGT) at this fixed rate of metabolic heat production on kidney function.

干预措施: 28.5°C WBGT - Fixed Work Rate (Other)

Fixed Work Rate

Experimental

Participants will walk on a treadmill at 3 mph and the grade will be adjusted to elicit 430 W of metabolic heat production (the most common work intensity). This study will systematically examine the NIOSH recommendations for prescribing work-to-rest ratios with increasing environmental heat stress (defined as Wet Bulb Globe Temperature, WBGT) at this fixed rate of metabolic heat production on kidney function.

干预措施: 35.5°C WBGT - Fixed Work Rate (Other)

Fixed work-to-rest ratio

Experimental

This study will systematically examine the NIOSH recommendations on changes in kidney function when the work-to-rest ratio is fixed at 30 min per hour (the most commonly prescribed work-to-rest ratio), but the rate of metabolic heat production and environmental heat stress differs (Figure 2). As described in Study 1, the appropriate rate of metabolic heat production will be elicited by having participants walk on a treadmill at 3 mph and the grade will be adjusted accordingly.

干预措施: 26.0°C WBGT - Fixed work-to-rest ratio (Other)

Fixed work-to-rest ratio

Experimental

This study will systematically examine the NIOSH recommendations on changes in kidney function when the work-to-rest ratio is fixed at 30 min per hour (the most commonly prescribed work-to-rest ratio), but the rate of metabolic heat production and environmental heat stress differs (Figure 2). As described in Study 1, the appropriate rate of metabolic heat production will be elicited by having participants walk on a treadmill at 3 mph and the grade will be adjusted accordingly.

干预措施: 30.5°C WBGT - Fixed work-to-rest ratio (Other)

Fixed work-to-rest ratio

Experimental

This study will systematically examine the NIOSH recommendations on changes in kidney function when the work-to-rest ratio is fixed at 30 min per hour (the most commonly prescribed work-to-rest ratio), but the rate of metabolic heat production and environmental heat stress differs (Figure 2). As described in Study 1, the appropriate rate of metabolic heat production will be elicited by having participants walk on a treadmill at 3 mph and the grade will be adjusted accordingly.

干预措施: 30.5°C WBGT - Fixed work-to-rest ratio (high intensity) (Other)

结局指标

主要结局

Peak urinary [IGFBP7•TIMP-2]

时间窗: through study completion, up to 20 weeks

Kidney injury marker

次要结局

  • Urinary IL-18(through study completion, up to 20 weeks)
  • Urinary NGAL(through study completion, up to 20 weeks)
  • Urinary TIMP-2(through study completion, up to 20 weeks)
  • Renal artery blood velocity(through study completion, up to 20 weeks)
  • Urinary L-FABP(through study completion, up to 20 weeks)
  • Urinary IGFBP7(through study completion, up to 20 weeks)
  • Segmental artery blood velocity(through study completion, up to 20 weeks)

研究者

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

Zachary J. Schlader

Associate Professor of Kinesiology

Indiana University

研究点 (1)

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