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NCT03678285 · ClinicalTrials.gov registry record · NA
Acute Renal Injury During High Intensity Training
A NA study, sponsored by University of Wyoming.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT03678285 is a NA study that has completed, run by University of Wyoming. The registered enrollment target is 42 participants.
The verdict
NCT03678285, a NA study, has completed, sponsored by University of Wyoming.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER HIFRT Workout
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03678285
The ClinicalTrials.gov registry entry for NCT03678285 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wyoming, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HIFRT Workout is the first listed.
NCT03678285 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03678285 about?
NCT03678285 is a clinical study titled "Acute Renal Injury During High Intensity Training". 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 kidn...
What is the current status of trial NCT03678285?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2018-10-01. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT03678285?
The interventions under investigation include: HIFRT Workout (OTHER).
Who is sponsoring clinical trial NCT03678285?
This trial is sponsored by University of Wyoming, which has 15 total clinical trials registered on ClinicalTrials.gov.
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