Dehydration Clinical Trial
Official title:
Renal Considerations in the Heat Stress and Hydration Recommendations (Aim 2)
NCT number | NCT05458843 |
Other study ID # | 15402 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2022 |
Est. completion date | May 22, 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 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.
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+. |
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 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04079543 -
NPO and Patient Satisfaction in the Cath Lab
|
N/A | |
Recruiting |
NCT06063655 -
Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults
|
N/A | |
Completed |
NCT05111392 -
Hydration Dynamics and Influence of Beverage Composition
|
Phase 1/Phase 2 | |
Terminated |
NCT02486224 -
Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance
|
N/A | |
Recruiting |
NCT02249845 -
Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children
|
N/A | |
Completed |
NCT01285713 -
IV Glucose for Dehydration Treatment
|
Phase 2 | |
Withdrawn |
NCT00691275 -
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
|
N/A | |
Completed |
NCT00360204 -
Improving Health Outcomes for New Mothers and Babies
|
Phase 3 | |
Completed |
NCT00370968 -
Zinc-ORS in Severe and Complicated Acute Diarrhea
|
Phase 2/Phase 3 | |
Completed |
NCT04076995 -
INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
|
N/A | |
Recruiting |
NCT05768789 -
Buoy Electrolyte Study on Hydration Status of Active Men and Women
|
N/A | |
Not yet recruiting |
NCT05428228 -
Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
|
N/A | |
Completed |
NCT04997031 -
Tap Water Intake and Perceptions in US Latinx Adults
|
||
Completed |
NCT04536324 -
The Absorption Rate of Subcutaneous Infused Fluid
|
||
Completed |
NCT02926989 -
Intravenous Fluids in Hospitalised Children
|
Phase 4 | |
Completed |
NCT04874584 -
Culturally Tailored Nurse Coaching Study for Cancer Symptom Management
|
N/A | |
Completed |
NCT02206581 -
Using Hydration Monitor to Detect Changes in the Hydration Status Athletes
|
N/A | |
Completed |
NCT02265575 -
Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration
|
Phase 2 | |
Completed |
NCT01893853 -
Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study)
|
N/A | |
Completed |
NCT01503996 -
Drinking Habits of Glaucoma Patients and Age Matched Controls
|
N/A |