Completed

NCT Number: NCT05458843

Renal Considerations in the Heat Stress Recommendations (Aim2)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hot Weather; Adverse Effect Body Temperature Changes Dehydration Heat Stress Disorders Hyperthermia Kidney Dysfunction Kidney Injury Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Water-Electrolyte Imbalance Wounds and Injuries

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Public Health

Bloomington, Indiana, 47405-7109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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+.

Treatment and study plan

Fluid replacement

Procedure

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

No fluid replacement

Procedure

Participants will not be permitted to drink.

Primary outcomes

Peak urinary thioredoxin

Time frame: Through study completion, up to twelve weeks

Marker of renal oxidative stress
Peak urinary MCP-1

Time frame: Through study completion, up to twelve weeks

Marker of renal inflammation

Secondary outcomes

Peak urinary [IGFBP7 x TIMP-2]

Time frame: Through study completion, up to twelve weeks

Kidney injury marker
Renal artery blood velocity

Time frame: Through study completion, up to twelve weeks

Measure of kidney blood flow
Segmental artery blood velocity

Time frame: Through study completion, up to twelve weeks

Measure of kidney blood flow

Other outcomes

Core body temperature

Time frame: Through study completion, up to twelve weeks

Heat strain variable
Mean skin temperature

Time frame: Through study completion, up to twelve weeks

Heat strain variable
Oxygen uptake

Time frame: Through study completion, up to twelve weeks

Heat strain variable
Heart rate

Time frame: Through study completion, up to twelve weeks

Heat strain variable
Blood pressure

Time frame: Through study completion, up to twelve weeks

Heat strain variable
Percentage change in body weight

Time frame: Through study completion, up to twelve weeks

Hydration status variable
Blood and plasma volume

Time frame: Through study completion, up to twelve weeks

Hydration status variable
Plasma osmolality

Time frame: Through study completion, up to twelve weeks

Hydration status variable
Urine osmolality

Time frame: Through study completion, up to twelve weeks

Hydration status variable
Urine specific gravity

Time frame: Through study completion, up to twelve weeks

Hydration status variable
Creatinine clearance

Time frame: Through study completion, up to twelve weeks

kidney function variable

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

State University of New York at Buffalo

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jul 14, 2022
Registry last updated: Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed