Clinical trial NCT05458843: Renal Considerations in the Heat Stress Recommendations (Aim2)
Official title: Renal Considerations in the Heat Stress and Hydration Recommendations (Aim 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Weather; Adverse Effect
Kidney Dysfunction
Kidney Injury
Hyperthermia
Dehydration
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: State University of New York at Buffalo
First posted: 2022-07-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: An epidemic of chronic kidney disease is occurring in laborers who undertake physical work outdoors in hot conditions. The reason for this is largely unknown, but may be related to kidney dysfunction caused by increases in body temperature and dehydration that elicit oxidative stress and inflammation in the renal tubules. The purpose of this study is to determine whether hydration status modifies the development of renal oxidative stress and inflammation.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not within defined age range
* Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2
* 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
* Answered "Yes" to any question on Page 1 of the PAR-Q+.

Primary outcomes:
measure: Peak urinary thioredoxin
timeFrame: Through study completion, up to twelve weeks
measure: Peak urinary MCP-1
timeFrame: Through study completion, up to twelve weeks
Secondary outcomes:
measure: Peak urinary [IGFBP7 x TIMP-2]
timeFrame: Through study completion, up to twelve weeks
measure: Renal artery blood velocity
timeFrame: Through study completion, up to twelve weeks
measure: Segmental artery blood velocity
timeFrame: Through study completion, up to twelve weeks
Other outcomes:
measure: Core body temperature
timeFrame: Through study completion, up to twelve weeks
measure: Mean skin temperature
timeFrame: Through study completion, up to twelve weeks
measure: Oxygen uptake
timeFrame: Through study completion, up to twelve weeks
measure: Heart rate
timeFrame: Through study completion, up to twelve weeks
measure: Blood pressure
timeFrame: Through study completion, up to twelve weeks
measure: Percentage change in body weight
timeFrame: Through study completion, up to twelve weeks
measure: Blood and plasma volume
timeFrame: Through study completion, up to twelve weeks
measure: Plasma osmolality
timeFrame: Through study completion, up to twelve weeks
measure: Urine osmolality
timeFrame: Through study completion, up to twelve weeks
measure: Urine specific gravity
timeFrame: Through study completion, up to twelve weeks
measure: Creatinine clearance
timeFrame: Through study completion, up to twelve weeks
Locations:
city: Bloomington
country: United States
facility: School of Public Health
state: Indiana
Study officials:
References: