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

July 31, 2020 updated by: Loris Juett, Loughborough University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
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
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.
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
Time Frame: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline
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)
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
Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma volume changes
Time Frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
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
Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Body mass changes
Time Frame: pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline
pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in creatine kinase
Time Frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
A marker of muscle damage
Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in lactate dehydrogenase
Time Frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
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).
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)
from post-exercise (immediately after the intervention) until 24 hours post-baseline
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 .
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
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 .
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
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 .
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
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 .
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
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
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
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 .
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
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 .
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
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 .
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
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 .
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
Time Frame: pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline
pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline
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
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
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
Will be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes)
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loughborough University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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