Differential Adaptation of Renal Function in Intense Physical Exercise

June 11, 2021 updated by: Armando Coca Rojo, Hospital Clínico Universitario de Valladolid

Differential Adaptation of Renal Function in Two Types of Intense Physical Exercise

In recent years there has been a significant increase in the number of participants in high intensity and duration sports events. This type of physical exercise has been reported to lead to an apparently transitory deterioration in kidney function. The injury mechanisms involved in this process have not been fully studied, but several have been proposed as potential causes, such as tissue ischemia, disruption of the permeability of the glomerular basement membrane, damage to the ultra-structure of skeletal muscle, structural involvement of the renal parenchyma, exercise-associated hyperthermia or insufficient hydration during exercise.

Urinary biomarkers, which are a more precise tool than serum creatinine when it comes to detecting subclinical kidney damage, may be key to elucidate the characteristics of exercise-related kidney injury.

The aim of this study is to carry out an integrative analysis of the development of exercise-associated subclinical acute kidney injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • 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

  • Spain
      • Valladolid, Spain, 47003
        • Hospital Clinico Universitario

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

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Able to understand the objectives of the study and to provide informed consent.
  • Body mass index between 18.5 and 24.9 kg / m2
  • Active sportsman/woman (defined as previous experience with the planned tests and performing vigorous-intensity aerobic activity at least three times per week).

Exclusion Criteria:

  • History of chronic kidney disease, hypertension, uncontrolled diabetes (defined as fasting glucose levels ≥200 mg/dl or HbA1c ≥9%), peripheral vascular disease, heart disease, neurological disease or thyroid disease.
  • Use of NSAIDs in the 72h prior to the test.
  • Consumption of statins or anabolic steroids.
  • Some kind of major physical injury in the four months prior to the tests.

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: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 10 km continuous running
Participants will perform a test of 10 km coninuous running.
Other: 10 km continuous running
Trial participants will perform a 10 km continuous running exercise
Other: 1.5 km continuous swimming
Trial participants will perform a 1.5 km continuous swimming exercise.
OTHER: 1.5 km swimming
Participants will perform a test of 1.5 km coninuous swimming.
Other: 10 km continuous running
Trial participants will perform a 10 km continuous running exercise
Other: 1.5 km continuous swimming
Trial participants will perform a 1.5 km continuous swimming exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels
Time Frame: 24 hours
24 hours
Absolute change in urinary Kidney Injury Molecule-1 (KIM-1) levels
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change in serum creatinine levels
Time Frame: 24 hours
24 hours
Absolute change in proteinuria
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Hospital Clínico Universitario de Valladolid

Collaborators

Instituto de Investigación Biomédica de Salamanca
Gerencia Regional de Salud de Castilla y Leon
Centro Regional de Medicina Deportiva de Castilla y León

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)

January 1, 2019

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

March 20, 2020

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (ACTUAL)

June 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-GR-18-914
  • GRS 1732A/18 (OTHER_GRANT: Gerencia Regional de Salud de Castilla y León)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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