Renal Considerations in the Heat Stress Recommendations (Aim2)

Dehydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05458843
• Other study ID #: 15402
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: May 22, 2023

Study information

• Verified date: November 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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+.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Fluid replacement
Participants will drink Gatorade Zero ad libitum, up to 1 cup every 15 minutes.
• No fluid replacement
Participants will not be permitted to drink.

Locations

Country	Name	City	State
United States	School of Public Health	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Core body temperature	Heat strain variable	Through study completion, up to twelve weeks
Other	Mean skin temperature	Heat strain variable	Through study completion, up to twelve weeks
Other	Oxygen uptake	Heat strain variable	Through study completion, up to twelve weeks
Other	Heart rate	Heat strain variable	Through study completion, up to twelve weeks
Other	Blood pressure	Heat strain variable	Through study completion, up to twelve weeks
Other	Percentage change in body weight	Hydration status variable	Through study completion, up to twelve weeks
Other	Blood and plasma volume	Hydration status variable	Through study completion, up to twelve weeks
Other	Plasma osmolality	Hydration status variable	Through study completion, up to twelve weeks
Other	Urine osmolality	Hydration status variable	Through study completion, up to twelve weeks
Other	Urine specific gravity	Hydration status variable	Through study completion, up to twelve weeks
Other	Creatinine clearance	kidney function variable	Through study completion, up to twelve weeks
Primary	Peak urinary thioredoxin	Marker of renal oxidative stress	Through study completion, up to twelve weeks
Primary	Peak urinary MCP-1	Marker of renal inflammation	Through study completion, up to twelve weeks
Secondary	Peak urinary [IGFBP7 x TIMP-2]	Kidney injury marker	Through study completion, up to twelve weeks
Secondary	Renal artery blood velocity	Measure of kidney blood flow	Through study completion, up to twelve weeks
Secondary	Segmental artery blood velocity	Measure of kidney blood flow	Through study completion, up to twelve weeks