Clinical trial NCT04140045: The Effect of Manipulating Hydration Status During Cycling in the Heat on Acute Kidney Injury Biomarkers
Official title: The Effect of Hypohydration During Cycling in the Heat on Acute Kidney Injury Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypohydrated
Euhydrated
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Healthy
* recreationally active

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in urinary Kidney Injury Molecule 1 (uKIM-1) (uncorrected/raw values and urine osmolality-corrected values)
timeFrame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
measure: Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values)
timeFrame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
measure: Changes in urine osmolality
timeFrame: Pre-exercise (baseline) and post-exercise (immediately after the intervention), as well as all urine produced from post-exercise until 24 hours post-baseline
measure: Changes in serum creatinine
timeFrame: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline
measure: Incidence of Acute Kidney Injury (as determined by changes in serum creatinine)
timeFrame: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline
Secondary outcomes:
measure: Plasma volume changes
timeFrame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
measure: Changes in serum osmolality
timeFrame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
measure: Body mass changes
timeFrame: pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline
measure: Changes in creatine kinase
timeFrame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
measure: Changes in lactate dehydrogenase
timeFrame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
measure: Ad libitum energy (Kj), carbohydrate (g), sugar (g), protein (g), fat (g), saturated fat (g), sodium (g) and water intake (g).
timeFrame: from post-exercise (immediately after the intervention) until 24 hours post-baseline
measure: Changes in headache scores
timeFrame: pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in nausea scores
timeFrame: pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in dizziness scores
timeFrame: pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in thirst scores
timeFrame: pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in thermal comfort scores
timeFrame: pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in gastrointestinal comfort scores
timeFrame: pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in stomach fullness scores
timeFrame: pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in stomach bloatedness scores
timeFrame: pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in urge to vomit scores
timeFrame: pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in urinary creatinine
timeFrame: pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline
measure: Changes in heart rate
timeFrame: Will 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)
measure: changes in rating of perceived exertion
timeFrame: Will be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes)
measure: Changes in aural temperature
timeFrame: Will 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)
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
Study officials:
References: