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

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.

Study Overview

• Status: Completed
• Conditions: Hypohydrated; Euhydrated
• Intervention / Treatment: Other: Water intake

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Loughborough, United Kingdom, LE11 3TU
    • Loughborough University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy
• recreationally active

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hypohydrated; Participants will be required to restrict their water intake during cycling in the heat (90-120 minutes at 35°C), in order to achieve a body mass loss of approximately 3%.	Other: Water intake; Water intake will be manipulated in both arms to create a hypohydrated state and a euhydrated state, post-exercise
EXPERIMENTAL: Euhydrated; Participants will be provided with water intake that matches their sweat losses during cycling in the heat (90-120 minutes at 35°C)	Other: Water intake; Water intake will be manipulated in both arms to create a hypohydrated state and a euhydrated state, post-exercise

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma volume changes		Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in serum osmolality	The gold standard marker of hydration status	Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Body mass changes		pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in creatine kinase	A marker of muscle damage	Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in lactate dehydrogenase	A marker of muscle damage	Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Ad libitum energy (Kj), carbohydrate (g), sugar (g), protein (g), fat (g), saturated fat (g), sodium (g) and water intake (g).	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)	from post-exercise (immediately after the intervention) until 24 hours post-baseline
Changes in headache scores	Participants will be asked to rate their headache on a scale of 0-10, with higher scores meaning a worse outcome .	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
Changes in nausea scores	Participants will be asked to rate their nausea on a scale of 0-10, with higher scores meaning a worse outcome .	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
Changes in dizziness scores	Participants will be asked to rate their dizziness on a scale of 0-10, with higher scores meaning a worse outcome .	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
Changes in thirst scores	Participants will be asked to rate their thirst on a scale of 0-10, with higher scores meaning a worse outcome .	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
Changes in thermal comfort scores	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	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
Changes in gastrointestinal comfort scores	Participants will be asked to rate their gastrointestinal comfort on a scale of 0-10, with higher scores meaning a worse outcome .	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
Changes in stomach fullness scores	Participants will be asked to rate their stomach fullness on a scale of 0-10, with higher scores meaning a worse outcome .	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
Changes in stomach bloatedness scores	Participants will be asked to rate their stomach bloatedness on a scale of 0-10, with higher scores meaning a worse outcome .	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
Changes in urge to vomit scores	Participants will be asked to rate their urge to vomit on a scale of 0-10, with higher scores meaning a worse outcome .	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
Changes in urinary creatinine		pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline
Changes in heart rate	Provides insight into exercise intensity	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)
changes in rating of perceived exertion	Provides insight into exercise intensity	Will be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes)
Changes in aural temperature	in-ear temperature	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)

Collaborators and Investigators

• Sponsor: Loughborough University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2019
• Primary Completion (ACTUAL): March 17, 2020
• Study Completion (ACTUAL): March 17, 2020

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: R19-P130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No