Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat

University of New Mexico (UNM)

Status and phase: Completed; Phase 1

Conditions: Acute Kidney Injury

Treatments: Drug: Placebo Corn Starch; Drug: Ibuprofen 600 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06247462

IBU2023

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

Ibuprofen

Experimental group

Description:

600 mg of Ibuprofen was ingested 12- and 1-hour prior to exercise.

Treatment:

Drug: Ibuprofen 600 mg

Placebo (Corn Starch)

Placebo Comparator group

Description:

600 mg of corn starch was ingested 12- and 1-hour prior to exercise.

Treatment:

Drug: Placebo Corn Starch