Renal Considerations in the Heat Stress Recommendations (Aim2)

NCT05458843 | Completed

• 1 other identifier: 15402
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Peak urinary thioredoxin

  Marker of renal oxidative stress

  Through study completion, up to twelve weeks

• Peak urinary MCP-1

  Marker of renal inflammation

  Through study completion, up to twelve weeks

Secondary Outcomes (3)

• Peak urinary [IGFBP7 x TIMP-2]

  Through study completion, up to twelve weeks

• Renal artery blood velocity

  Through study completion, up to twelve weeks

• Segmental artery blood velocity

  Through study completion, up to twelve weeks

Other Outcomes (11)

• Core body temperature

  Through study completion, up to twelve weeks

• Mean skin temperature

  Through study completion, up to twelve weeks

• Oxygen uptake

  Through study completion, up to twelve weeks

Study Arms (2)

Fluid replacement

EXPERIMENTAL

Procedure: Fluid replacement

No fluid replacement

SHAM COMPARATOR

Procedure: No fluid replacement

Interventions

Fluid replacement PROCEDURE

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

Fluid replacement

No fluid replacement PROCEDURE

Participants will not be permitted to drink.

No fluid replacement

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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+.

Sponsors & Collaborators

• Indiana University: lead
• State University of New York at Buffalo: collaborator

Study Sites (1)

School of Public Health

Bloomington, Indiana, 47405-7109, United States

Location

MeSH Terms

Conditions

Hyperthermia; Dehydration

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Kinesiology

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: August 1, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

US (1)