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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Ibuprofen 600 mg; Drug: Placebo Corn Starch

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Exercise Physiology Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen; 600 mg of Ibuprofen was ingested 12- and 1-hour prior to exercise.	Drug: Ibuprofen 600 mg; 600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise.
Placebo Comparator: Placebo (Corn Starch); 600 mg of corn starch was ingested 12- and 1-hour prior to exercise.	Drug: Placebo Corn Starch; 600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (IGFBP7xTIMP2)	The product of urinary IGFBP7 and urinary TIMP2 (IGFBP7xTIMP2) will be measured at all time points.	Change in urinary IGFBP7xTIMP2 pre-exercise and 1 hour post-exercise.
Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (Urinary NGAL)	Urinary NGAL will be measured at all time points.	Change in urinary NGAL pre-exercise and peak post-exercise.
Biomarker of glomerular filtration rate from Ibuprofen Ingestion Prior to Exercise in the Heat (Serum cystatin C)	Serum cystatin C will be measured at all time points.	Change in serum cystatin C pre-exercise and 1 hour post-exercise.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating Marker of Intestinal Injury from Ibuprofen Ingestion Prior to Exercise in the Heat	Plasma I-FABP is a circulating marker of intestinal damage.	Change in plasma I-FABP from pre- to immediately 1 hour post-exercise.
Circulating Marker of Intestinal Permeability from Ibuprofen Ingestion Prior to Exercise in the Heat	Plasma LBP is a circulating marker of intestinal permeability.	Change in plasma LBP from pre- to immediately 1 hour post-exercise.
Circulating Marker of Endotoxemia from Ibuprofen Ingestion Prior to Exercise in the Heat	Plasma sCD14 is a circulating marker of endotoxemia.	Change in plasma sCD14 from pre- to immediately 1 hour post-exercise.

Collaborators and Investigators

• Sponsor: University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): September 5, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Phenylpropionates; Ibuprofen
• Other Study ID Numbers: IBU2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes