Renal Considerations in the Heat Stress Recommendations (Aim2)
Primary Purpose
Hot Weather; Adverse Effect, Kidney Dysfunction, Kidney Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluid replacement
No fluid replacement
Sponsored by
About this trial
This is an interventional basic science trial for Hot Weather; Adverse Effect
Eligibility Criteria
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+.
Sites / Locations
- School of Public HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Fluid replacement
No fluid replacement
Arm Description
Outcomes
Primary Outcome Measures
Peak urinary thioredoxin
Marker of renal oxidative stress
Peak urinary interleukin-18
Marker of renal inflammation
Secondary Outcome Measures
Peak urinary [IGFBP7 x TIMP-2]
Kidney injury marker
Renal artery blood velocity
Measure of kidney blood flow
Segmental artery blood velocity
Measure of kidney blood flow
Plasma NGAL
Kidney injury marker
Urinary NGAL
Kidney injury marker
Urinary L-FABP
Kidney injury marker
Full Information
NCT ID
NCT05458843
First Posted
July 11, 2022
Last Updated
September 26, 2023
Sponsor
Indiana University
Collaborators
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT05458843
Brief Title
Renal Considerations in the Heat Stress Recommendations (Aim2)
Official Title
Renal Considerations in the Heat Stress and Hydration Recommendations (Aim 2)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Weather; Adverse Effect, Kidney Dysfunction, Kidney Injury, Hyperthermia, Dehydration
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluid replacement
Arm Type
Experimental
Arm Title
No fluid replacement
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Fluid replacement
Intervention Description
Participants will drink Gatorade Zero ad libitum, up to 1 cup every 15 minutes.
Intervention Type
Procedure
Intervention Name(s)
No fluid replacement
Intervention Description
Participants will not be permitted to drink.
Primary Outcome Measure Information:
Title
Peak urinary thioredoxin
Description
Marker of renal oxidative stress
Time Frame
Through study completion, up to twelve weeks
Title
Peak urinary interleukin-18
Description
Marker of renal inflammation
Time Frame
Through study completion, up to twelve weeks
Secondary Outcome Measure Information:
Title
Peak urinary [IGFBP7 x TIMP-2]
Description
Kidney injury marker
Time Frame
Through study completion, up to twelve weeks
Title
Renal artery blood velocity
Description
Measure of kidney blood flow
Time Frame
Through study completion, up to twelve weeks
Title
Segmental artery blood velocity
Description
Measure of kidney blood flow
Time Frame
Through study completion, up to twelve weeks
Title
Plasma NGAL
Description
Kidney injury marker
Time Frame
Through study completion, up to twelve weeks
Title
Urinary NGAL
Description
Kidney injury marker
Time Frame
Through study completion, up to twelve weeks
Title
Urinary L-FABP
Description
Kidney injury marker
Time Frame
Through study completion, up to twelve weeks
Other Pre-specified Outcome Measures:
Title
Core body temperature
Description
Heat strain variable
Time Frame
Through study completion, up to twelve weeks
Title
Mean skin temperature
Description
Heat strain variable
Time Frame
Through study completion, up to twelve weeks
Title
Oxygen uptake
Description
Heat strain variable
Time Frame
Through study completion, up to twelve weeks
Title
Heart rate
Description
Heat strain variable
Time Frame
Through study completion, up to twelve weeks
Title
Blood pressure
Description
Heat strain variable
Time Frame
Through study completion, up to twelve weeks
Title
Percentage change in body weight
Description
Hydration status variable
Time Frame
Through study completion, up to twelve weeks
Title
Blood and plasma volume
Description
Hydration status variable
Time Frame
Through study completion, up to twelve weeks
Title
Plasma osmolality
Description
Hydration status variable
Time Frame
Through study completion, up to twelve weeks
Title
Urine osmolality
Description
Hydration status variable
Time Frame
Through study completion, up to twelve weeks
Title
Urine specific gravity
Description
Hydration status variable
Time Frame
Through study completion, up to twelve weeks
Title
Creatinine clearance
Description
kidney function variable
Time Frame
Through study completion, up to twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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+.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zachary J Schlader, PhD
Phone
8128556953
Email
zschlade@iu.edu
Facility Information:
Facility Name
School of Public Health
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405-7109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Schlader
Phone
812-855-6953
Email
zschlade@indiana.edu
12. IPD Sharing Statement
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Renal Considerations in the Heat Stress Recommendations (Aim2)
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