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Completed

NCT Number: NCT04140045

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

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.

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Key information

Conditions

Hypohydrated Euhydrated

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • recreationally active

Exclusion criteria

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

Treatment and study plan

water intake

Other

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

Primary outcomes

  1. Changes in urinary Kidney Injury Molecule 1 (uKIM-1) (uncorrected/raw values and urine osmolality-corrected values)

    Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline

    A novel protein biomarker for acute kidney injury

  2. Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values)

    Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline

    A novel protein biomarker for acute kidney injury

  3. Changes in urine osmolality

    Time frame: Pre-exercise (baseline) and post-exercise (immediately after the intervention), as well as all urine produced from post-exercise until 24 hours post-baseline

    A measure of urine concentration.

  4. Changes in serum creatinine

    Time frame: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline

    Serum creatinine is a marker of kidney function

  5. Incidence of Acute Kidney Injury (as determined by changes in serum creatinine)

    Time frame: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline

    A rise in serum creatinine of 1.5 fold or more from baseline will be defined as acute kidney injury

Secondary outcomes

  1. Plasma volume changes

    Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline

  2. Changes in serum osmolality

    Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline

    The gold standard marker of hydration status

  3. Body mass changes

    Time frame: pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline

  4. Changes in creatine kinase

    Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline

    A marker of muscle damage

  5. Changes in lactate dehydrogenase

    Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline

    A marker of muscle damage

  6. Ad libitum energy (Kj), carbohydrate (g), sugar (g), protein (g), fat (g), saturated fat (g), sodium (g) and water intake (g).

    Time frame: from post-exercise (immediately after the intervention) until 24 hours post-baseline

    Participants 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)

  7. Changes in headache scores

    Time frame: 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

    Participants will be asked to rate their headache on a scale of 0-10, with higher scores meaning a worse outcome .

  8. Changes in nausea scores

    Time frame: 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

    Participants will be asked to rate their nausea on a scale of 0-10, with higher scores meaning a worse outcome .

  9. Changes in dizziness scores

    Time frame: 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

    Participants will be asked to rate their dizziness on a scale of 0-10, with higher scores meaning a worse outcome .

  10. Changes in thirst scores

    Time frame: 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

    Participants will be asked to rate their thirst on a scale of 0-10, with higher scores meaning a worse outcome .

  11. Changes in thermal comfort scores

    Time frame: 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

    Participants 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

  12. Changes in gastrointestinal comfort scores

    Time frame: 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

    Participants will be asked to rate their gastrointestinal comfort on a scale of 0-10, with higher scores meaning a worse outcome .

  13. Changes in stomach fullness scores

    Time frame: 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

    Participants will be asked to rate their stomach fullness on a scale of 0-10, with higher scores meaning a worse outcome .

  14. Changes in stomach bloatedness scores

    Time frame: 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

    Participants will be asked to rate their stomach bloatedness on a scale of 0-10, with higher scores meaning a worse outcome .

  15. Changes in urge to vomit scores

    Time frame: 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

    Participants will be asked to rate their urge to vomit on a scale of 0-10, with higher scores meaning a worse outcome .

  16. Changes in urinary creatinine

    Time frame: pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline

  17. Changes in heart rate

    Time frame: 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)

    Provides insight into exercise intensity

  18. changes in rating of perceived exertion

    Time frame: Will be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes)

    Provides insight into exercise intensity

  19. Changes in aural temperature

    Time frame: 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)

    in-ear temperature

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2019
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.