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| Name | Class |
|---|---|
| State University of New York at Buffalo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluid replacement | Experimental |
| |
| No fluid replacement | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid replacement | Procedure | Participants will drink Gatorade Zero ad libitum, up to 1 cup every 15 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak urinary [IGFBP7 x TIMP-2] | Kidney injury marker | Through study completion, up to twelve weeks |
| Renal artery blood velocity | Measure of kidney blood flow |
| Measure | Description | Time Frame |
|---|---|---|
| Core body temperature | Heat strain variable | Through study completion, up to twelve weeks |
| Mean skin temperature | Heat strain variable | Through study completion, up to twelve weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Public Health | Bloomington | Indiana | 47405-7109 | United States |
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| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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| No fluid replacement | Procedure | Participants will not be permitted to drink. |
|
| Through study completion, up to twelve weeks |
| Segmental artery blood velocity | Measure of kidney blood flow | Through study completion, up to twelve weeks |
| Oxygen uptake | Heat strain variable | Through study completion, up to twelve weeks |
| Heart rate | Heat strain variable | Through study completion, up to twelve weeks |
| Blood pressure | Heat strain variable | Through study completion, up to twelve weeks |
| Percentage change in body weight | Hydration status variable | Through study completion, up to twelve weeks |
| Blood and plasma volume | Hydration status variable | Through study completion, up to twelve weeks |
| Plasma osmolality | Hydration status variable | Through study completion, up to twelve weeks |
| Urine osmolality | Hydration status variable | Through study completion, up to twelve weeks |
| Urine specific gravity | Hydration status variable | Through study completion, up to twelve weeks |
| Creatinine clearance | kidney function variable | Through study completion, up to twelve weeks |
| D014947 | Wounds and Injuries |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |