Dehydration Clinical Trial
— Aim1Official title:
Renal Considerations in the Heat Stress Recommendations
NCT number | NCT04767347 |
Other study ID # | 1902420140 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | May 4, 2023 |
Verified date | November 2023 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An epidemic of chronic kidney disease is occurring in laborers who undertake physical work outdoors in hot conditions. The reason for this is unknown, but may be related to kidney dysfunction caused by increases in body temperature and dehydration. The current heat stress recommendations for workers were not developed with regards for kidney health. The purpose of this study is to determine if the current recommendations protect against kidney dysfunction.
Status | Completed |
Enrollment | 38 |
Est. completion date | May 4, 2023 |
Est. primary completion date | May 4, 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 - Deemed highly active according to the physical activity questionnaire (i.e., >3500 MET*min/wk) - 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 - Inability to safely complete the peak oxygen uptake test |
Country | Name | City | State |
---|---|---|---|
United States | School of Public Health | Bloomington | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | State University of New York at Buffalo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Core body temperature | Heat strain variable | through study completion, up to 20 weeks | |
Other | Mean skin temperature | Heat strain variable | through study completion, up to 20 weeks | |
Other | Oxygen uptake | Heat strain variable | through study completion, up to 20 weeks | |
Other | Heart rate | Heat strain variable | through study completion, up to 20 weeks | |
Other | Blood pressure | Heat strain variable | through study completion, up to 20 weeks | |
Other | Whole-body sweat rate | Hydration and heat strain variable | through study completion, up to 20 weeks | |
Other | Percentage change in body weight | Hydration status variable | through study completion, up to 20 weeks | |
Other | Plasma osmolality | Hydration status variable | through study completion, up to 20 weeks | |
Other | Urine osmolality | Hydration status variable | through study completion, up to 20 weeks | |
Other | Blood and plasma volume | Hydration status variable | through study completion, up to 20 weeks | |
Other | Urine specific gravity | Hydration status variable | through study completion, up to 20 weeks | |
Other | Plasma copeptin | Hydration status variable | through study completion, up to 20 weeks | |
Other | Creatinine clearance | Kidney function variable | through study completion, up to 20 weeks | |
Other | Fractional excretion of electrolytes | Kidney function variable | through study completion, up to 20 weeks | |
Other | Free water clearance | Kidney function variable | through study completion, up to 20 weeks | |
Other | Serum uric acid | Kidney function variable | through study completion, up to 20 weeks | |
Other | Urinary uric acid | Kidney function variable | through study completion, up to 20 weeks | |
Primary | Peak urinary [IGFBP7•TIMP-2] | Kidney injury marker | through study completion, up to 20 weeks | |
Secondary | Urinary NGAL | Kidney injury marker | through study completion, up to 20 weeks | |
Secondary | Urinary IGFBP7 | Kidney injury marker | through study completion, up to 20 weeks | |
Secondary | Urinary TIMP-2 | Kidney injury marker | through study completion, up to 20 weeks | |
Secondary | Urinary IL-18 | Kidney injury marker | through study completion, up to 20 weeks | |
Secondary | Urinary L-FABP | Kidney injury marker | through study completion, up to 20 weeks | |
Secondary | Renal artery blood velocity | Index of kidney blood flow | through study completion, up to 20 weeks | |
Secondary | Segmental artery blood velocity | Index of kidney blood flow | through study completion, up to 20 weeks |
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