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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06247462
• Other study ID #: IBU2023
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2023
• Est. completion date: September 5, 2023

Study information

• Verified date: February 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Drug:
• Ibuprofen 600 mg
600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise.
• Placebo Corn Starch
600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise.

Locations

Country	Name	City	State
United States	Exercise Physiology Lab	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of Acute Kidney Injury from Ibuprofen Ingestion Prior to Exercise in the Heat	Urinary IGFBP7, TIMP2, and NGAL, and serum cystatin C concentrations will be assessed at all time points.	Change in urinary IFGBP7 multiplied by urinary TIMP2, urinary NGAL, and serum Cystatin C pre-exercise, immediately post-exercise and 1-hour post-exercise.
Secondary	Circulating Markers of Intestinal Permeability from Ibuprofen Ingestion Prior to Exercise in the Heat	Plasma LBP and I-FABP are circulating markers of intestinal permeability and damage.	Change in plasma LBP and I-FABP from pre- to immediately post-exercise.