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Renal Considerations in the Heat Stress Recommendations (Aim2)

Renal Considerations in the Heat Stress and Hydration Recommendations (Aim 2)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05458843
Enrollment
18
Registered
2022-07-14
Start date
2022-08-01
Completion date
2023-05-22
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Hot Weather; Adverse Effect, Hyperthermia, Kidney Dysfunction, Kidney Injury

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.

Interventions

PROCEDUREFluid replacement

Participants will drink Gatorade Zero ad libitum, up to 1 cup every 15 minutes.

PROCEDURENo fluid replacement

Participants will not be permitted to drink.

Sponsors

State University of New York at Buffalo
CollaboratorOTHER
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes

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+.

Design outcomes

Primary

MeasureTime frameDescription
Peak urinary thioredoxinThrough study completion, up to twelve weeksMarker of renal oxidative stress
Peak urinary MCP-1Through study completion, up to twelve weeksMarker of renal inflammation

Secondary

MeasureTime frameDescription
Peak urinary [IGFBP7 x TIMP-2]Through study completion, up to twelve weeksKidney injury marker
Renal artery blood velocityThrough study completion, up to twelve weeksMeasure of kidney blood flow
Segmental artery blood velocityThrough study completion, up to twelve weeksMeasure of kidney blood flow

Other

MeasureTime frameDescription
Percentage change in body weightThrough study completion, up to twelve weeksHydration status variable
Blood and plasma volumeThrough study completion, up to twelve weeksHydration status variable
Plasma osmolalityThrough study completion, up to twelve weeksHydration status variable
Core body temperatureThrough study completion, up to twelve weeksHeat strain variable
Urine specific gravityThrough study completion, up to twelve weeksHydration status variable
Creatinine clearanceThrough study completion, up to twelve weekskidney function variable
Urine osmolalityThrough study completion, up to twelve weeksHydration status variable
Mean skin temperatureThrough study completion, up to twelve weeksHeat strain variable
Oxygen uptakeThrough study completion, up to twelve weeksHeat strain variable
Heart rateThrough study completion, up to twelve weeksHeat strain variable
Blood pressureThrough study completion, up to twelve weeksHeat strain variable

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026