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

January 22, 2026 updated by: University of New Mexico
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: Change in urinary NGAL pre-exercise and peak post-exercise.
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)
Time Frame: Change in serum cystatin C pre-exercise and 1 hour post-exercise.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Change in plasma LBP from pre- to immediately 1 hour post-exercise.
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
Time Frame: Change in plasma sCD14 from pre- to immediately 1 hour post-exercise.
Plasma sCD14 is a circulating marker of endotoxemia.
Change in plasma sCD14 from pre- to immediately 1 hour post-exercise.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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