NCT04140045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

October 21, 2019

Last Update Submit

July 31, 2020

Conditions

HypohydratedEuhydrated

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (19)

  • Plasma volume changes

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

  • Changes in serum osmolality

    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

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

  • Changes in lactate dehydrogenase

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

  • +14 more secondary outcomes

Study Arms (2)

Hypohydrated

EXPERIMENTAL

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

Euhydrated

EXPERIMENTAL

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

Interventions

Water intakeOTHER

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

EuhydratedHypohydrated

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • recreationally active

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

MeSH Terms

Interventions

Drinking

Intervention Hierarchy (Ancestors)

EatingNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 25, 2019

Study Start

October 28, 2019

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

August 3, 2020

Record last verified: 2020-07

Locations

GB(1)