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Completed

NCT Number: NCT06247462

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Exercise Physiology Lab

Albuquerque, New Mexico, 87131, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ibuprofen 600 mg

Drug

600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise.

Placebo Corn Starch

Drug

600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise.

Primary outcomes

  1. Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (IGFBP7xTIMP2)

    Time frame: 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.

  2. Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (Urinary NGAL)

    Time frame: Change in urinary NGAL pre-exercise and peak post-exercise.

    Urinary NGAL will be measured at all time points.

  3. Biomarker of glomerular filtration rate from Ibuprofen Ingestion Prior to Exercise in the Heat (Serum cystatin C)

    Time frame: Change in serum cystatin C pre-exercise and 1 hour post-exercise.

    Serum cystatin C will be measured at all time points.

Secondary outcomes

  1. Circulating Marker of Intestinal Injury from Ibuprofen Ingestion Prior to Exercise in the Heat

    Time frame: Change in plasma I-FABP from pre- to immediately 1 hour post-exercise.

    Plasma I-FABP is a circulating marker of intestinal damage.

  2. Circulating Marker of Intestinal Permeability from Ibuprofen Ingestion Prior to Exercise in the Heat

    Time frame: Change in plasma LBP from pre- to immediately 1 hour post-exercise.

    Plasma LBP is a circulating marker of intestinal permeability.

  3. Circulating Marker of Endotoxemia from Ibuprofen Ingestion Prior to Exercise in the Heat

    Time frame: Change in plasma sCD14 from pre- to immediately 1 hour post-exercise.

    Plasma sCD14 is a circulating marker of endotoxemia.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2024
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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