Acute Kidney Injury
Conditions
Brief summary
The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at moderate intensity. Urine, plasma, and serum samples were collected pre-, post-, and 1hour post-exercise to assess biomarkers of acute kidney injury. This was a double blind, randomized crossover design, so that participants completed the alternate trial (ibuprofen or placebo) at least seven days later.
Interventions
DRUGIbuprofen 600 mg
600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise.
600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise.
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Physically active (engage in at least 150 minutes of moderate to vigorous intensity exercise per week) * between the ages of 18 and 45 * Able to run continuously for at least 60 minutes * Able to speak and read English.
Exclusion criteria
* Non-English speakers, prisoners, pregnant women, or persons requiring a LAR * Previous history of heat stroke or heat illness * Currently experiencing a sunburn or other burn injury * Have repeated exposure to heat, such as hot baths, sauna, or travel to a hot environment * Has resided in a hot climate within 2 months prior to the trial * Answered "yes" to at least one question on the physical activity readiness questionnaire * Shows signs or symptoms of or are known to have cardiovascular, renal, metabolic, or pulmonary disease as determined by a health questionnaire * Are a current smoker * History of regular gastrointestinal distress * Known history of stomach ulcers or taking blood thinning medication * Known allergy to ibuprofen * Have a resting blood pressure greater than 140 systolic or 90 diastolic * Do not engage in at least 150 minutes of moderate to vigorous intensity exercise per week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (IGFBP7xTIMP2) | Change in urinary IGFBP7xTIMP2 pre-exercise and 1 hour post-exercise. | The product of urinary IGFBP7 and urinary TIMP2 (IGFBP7xTIMP2) will be measured at all time points. |
| Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (Urinary NGAL) | Change in urinary NGAL pre-exercise and peak post-exercise. | Urinary NGAL will be measured at all time points. |
| Biomarker of glomerular filtration rate from Ibuprofen Ingestion Prior to Exercise in the Heat (Serum cystatin C) | Change in serum cystatin C pre-exercise and 1 hour post-exercise. | Serum cystatin C will be measured at all time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circulating Marker of Intestinal Injury from Ibuprofen Ingestion Prior to Exercise in the Heat | Change in plasma I-FABP from pre- to immediately 1 hour post-exercise. | Plasma I-FABP is a circulating marker of intestinal damage. |
| Circulating Marker of Intestinal Permeability from Ibuprofen Ingestion Prior to Exercise in the Heat | Change in plasma LBP from pre- to immediately 1 hour post-exercise. | Plasma LBP is a circulating marker of intestinal permeability. |
| Circulating Marker of Endotoxemia from Ibuprofen Ingestion Prior to Exercise in the Heat | Change in plasma sCD14 from pre- to immediately 1 hour post-exercise. | Plasma sCD14 is a circulating marker of endotoxemia. |
Countries
United States
Outcome results
None listed