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

Phase 1

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Ibuprofen 600 mg; Drug: Placebo Corn Starch

• Registration Number: NCT06247462
• Lead Sponsor: University of New Mexico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-09-05
• Study Completion: 2023-09-05
• Study First Submitted: 2023-12-19
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-05
• Last Update Submitted: 2024-02-05
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Participants will be physically active males and females between the ages of 18 and 45. Participants will be able to run continuously for at least 60 minutes. All will be able to speak and read English.

Exclusion Criteria

1. non-English speakers, prisoners, pregnant women, or persons requiring a LAR will not be included
2. previous history of heat stroke or heat illness
3. currently experiencing a sunburn or other burn injury
4. have repeated exposure to heat, such as hot baths, sauna, or travel to a hot environment
5. has resided in a hot climate within 2 months prior to the trial
6. answered "yes" to at least one question on the physical activity readiness questionnaire,
7. show signs or symptoms of or are known to have cardiovascular, renal, metabolic, or pulmonary disease as determined by a health questionnaire
8. are a current smoker,
9. history of regular gastrointestinal distress,
10. known history of stomach ulcers or taking blood thinning medication,
11. known allergy to caffeine
12. have a resting blood pressure greater than 140 systolic or 90 diastolic, and
13. do not engage in at least 150 minutes of moderate to vigorous intensity exercise per week.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen 600 mg	600 mg of Ibuprofen was ingested 12- and 1-hour prior to exercise.
Placebo (Corn Starch)	Placebo Corn Starch	600 mg of corn starch was ingested 12- and 1-hour prior to exercise.

Primary Outcome Measures

Name	Time	Method
Biomarkers of Acute Kidney Injury from Ibuprofen Ingestion Prior to Exercise in the Heat	Change in urinary IFGBP7 multiplied by urinary TIMP2, urinary NGAL, and serum Cystatin C pre-exercise, immediately post-exercise and 1-hour post-exercise.	Urinary IGFBP7, TIMP2, and NGAL, and serum cystatin C concentrations will be assessed at all time points.

Secondary Outcome Measures

Name	Time	Method
Circulating Markers of Intestinal Permeability from Ibuprofen Ingestion Prior to Exercise in the Heat	Change in plasma LBP and I-FABP from pre- to immediately post-exercise.	Plasma LBP and I-FABP are circulating markers of intestinal permeability and damage.

Trial Locations

Locations (1)

Exercise Physiology Lab; 🇺🇸 Albuquerque, New Mexico, United States