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The Effect of Manipulating Hydration Status During Cycling in the Heat on Acute Kidney Injury Biomarkers

The Effect of Hypohydration During Cycling in the Heat on Acute Kidney Injury Biomarkers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04140045
Enrollment
14
Registered
2019-10-25
Start date
2019-10-28
Completion date
2020-03-17
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypohydrated, Euhydrated

Brief summary

Acute Kidney Injury (AKI) is common in prolonged endurance events. Risk factors for exercise-associated AKI include: the exercise itself, heat, hypohydration, muscle breakdown and non-steroidal anti-inflammatory drug (NSAID) use. Prior research from our laboratory showed the hypohydration during high-intensity running increased a biomarker of AKI (urine osmolality-corrected kidney injury molecule 1). Therefore, the current study will now investigate the effect of manipulating hydration status during cycling on biomarkers of AKI.

Interventions

Water intake will be manipulated in both arms to create a hypohydrated state and a euhydrated state, post-exercise

Sponsors

Loughborough University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy * recreationally active

Exclusion criteria

* Smoker/vaper * regular use of anti-inflammatory medications (e.g. ibuprofen) * history of kidney disease or diabetes

Design outcomes

Primary

MeasureTime frameDescription
Changes in urinary Kidney Injury Molecule 1 (uKIM-1) (uncorrected/raw values and urine osmolality-corrected values)Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baselineA novel protein biomarker for acute kidney injury
Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values)Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baselineA novel protein biomarker for acute kidney injury
Changes in urine osmolalityPre-exercise (baseline) and post-exercise (immediately after the intervention), as well as all urine produced from post-exercise until 24 hours post-baselineA measure of urine concentration.
Changes in serum creatininePre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baselineSerum creatinine is a marker of kidney function
Incidence of Acute Kidney Injury (as determined by changes in serum creatinine)Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baselineA rise in serum creatinine of 1.5 fold or more from baseline will be defined as acute kidney injury

Secondary

MeasureTime frameDescription
Ad libitum energy (Kj), carbohydrate (g), sugar (g), protein (g), fat (g), saturated fat (g), sodium (g) and water intake (g).from post-exercise (immediately after the intervention) until 24 hours post-baselineParticipants will complete a weighed food and fluid diary, using a set of food scales and a diary, to record all food and fluid that they ingest. This data will then be analysed using dietary analysis software (e.g. Nutritics)
Changes in headache scorespre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baselineParticipants will be asked to rate their headache on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in nausea scorespre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baselineParticipants will be asked to rate their nausea on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in dizziness scorespre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baselineParticipants will be asked to rate their dizziness on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in thirst scorespre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baselineParticipants will be asked to rate their thirst on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in thermal comfort scorespre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baselineParticipants will be asked to rate their thermal comfort on a scale of -10 to 10, with -10 being cold impossible to bear and 10 being heat impossible to bear
Changes in gastrointestinal comfort scorespre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baselineParticipants will be asked to rate their gastrointestinal comfort on a scale of 0-10, with higher scores meaning a worse outcome .
Plasma volume changesPre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in stomach bloatedness scorespre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baselineParticipants will be asked to rate their stomach bloatedness on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in urge to vomit scorespre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baselineParticipants will be asked to rate their urge to vomit on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in urinary creatininepre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline
Changes in heart rateWill be monitored throughout the exercise intervention, at 15 minute intervals (15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes and 120 minutes)Provides insight into exercise intensity
changes in rating of perceived exertionWill be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes)Provides insight into exercise intensity
Changes in aural temperatureWill be determined immediately prior to the exercise intervention (at rest) and then throughout the exercise intervention at 15 minute intervals (15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes and 120 minutes)in-ear temperature
Changes in stomach fullness scorespre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baselineParticipants will be asked to rate their stomach fullness on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in serum osmolalityPre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baselineThe gold standard marker of hydration status
Body mass changespre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in creatine kinasePre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baselineA marker of muscle damage
Changes in lactate dehydrogenasePre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baselineA marker of muscle damage

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026