Renal Considerations in the Heat Stress Recommendations (Aim2)

NCT ID: NCT05458843

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-05-22

Brief Summary

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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.

Detailed Description

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Conditions

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Hot Weather; Adverse Effect Kidney Dysfunction Kidney Injury Hyperthermia Dehydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fluid replacement

Group Type EXPERIMENTAL

Fluid replacement

Intervention Type PROCEDURE

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

No fluid replacement

Group Type SHAM_COMPARATOR

No fluid replacement

Intervention Type PROCEDURE

Participants will not be permitted to drink.

Interventions

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Fluid replacement

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

Intervention Type PROCEDURE

No fluid replacement

Participants will not be permitted to drink.

Intervention Type PROCEDURE

Eligibility Criteria

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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+.
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Zachary J. Schlader

Associate Professor Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Public Health

Bloomington, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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15402

Identifier Type: -

Identifier Source: org_study_id

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