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Completed Not applicable Interventional Accepts healthy volunteers Results available

Acute Renal Injury During High Intensity Training

ClinicalTrials.gov ID: NCT03678285

Public ClinicalTrials.gov record NCT03678285. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Hematological Risk Factors Related to Acute Renal Injury During High Intensity Training

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The proposed work is designed to be the first in a series of studies investigating the health benefits and risks related to high intensity training (HIT) exercise. Our specific aims are to determine, 1) if participation in a single bout of HIT induces hematological markers consistent with acute kidney injury (AKI), and 2) if risk is predicted by the pre-exercise concentration of plasma proenkephalin-A. This investigation is an observational case control study. In year one, data collection procedures will be refined with \~40 participants local to the University of Wyoming and training will occur for collaborators from Wyoming community and tribal colleges. In year two, data collection will expand to some of the 12 CrossFit® gyms in Wyoming with assistance from the community and tribal colleges. Blood and urine samples will be collected before and up to 48 h after a standardized bout of HIT exercise on \~100 participants. Baseline blood samples will be analyzed for proenkephalin-A. All blood samples will be analyzed for markers of muscle damage (e.g., creatine kinase and myoglobin), and markers of kidney function (e.g., serum creatinine and blood urea nitrogen). Urine will be analyzed for markers of filtration function (e.g., albumin, creatinine, neutrophil gelatinase-associated lipocalin \[NGAL\], and kidney injury molecule 1 \[KIM-1\]). Lastly, the severity of kidney damage will be compared with the number of risk alleles and proenkephalin-A concentration. The investigators envision that the bout of HIT exercise will induce markers consistent with skeletal muscle damage in most participants and, based on literature from other styles of intense exercise, that acute kidney injury will be diagnosable in between 50-75% of participants. Secondarily, the investigators predict that the concentration of proenkephalin-A will be inversely related to the change in kidney function from before to after the HIT exercise bout.

Study identification

NCT ID
NCT03678285
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Wyoming
Other
Enrollment
42 participants

Conditions and interventions

Interventions

Other

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2018
Primary completion
May 29, 2019
Completion
Jun 29, 2019
Last update posted
Jul 15, 2021

2018 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Wyoming Laramie Wyoming 82071

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03678285, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 15, 2021 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03678285 live on ClinicalTrials.gov.

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