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Differential Adaptation of Renal Function in Intense Physical Exercise

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
10 km continuous running
1.5 km continuous swimming
Sponsored by
Hospital Clínico Universitario de Valladolid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Kidney Injury focused on measuring Acute kidney injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Clínico Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

10 km continuous running

1.5 km swimming

Arm Description

Participants will perform a test of 10 km coninuous running.

Participants will perform a test of 1.5 km coninuous swimming.

Outcomes

Primary Outcome Measures

Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels
Absolute change in urinary Kidney Injury Molecule-1 (KIM-1) levels

Secondary Outcome Measures

Absolute change in serum creatinine levels
Absolute change in proteinuria

Full Information

First Posted
June 11, 2021
Last Updated
June 11, 2021
Sponsor
Hospital Clínico Universitario de Valladolid
Collaborators
Gerencia Regional de Salud de Castilla y León, Instituto de Investigación Biomédica de Salamanca, Centro Regional de Medicina Deportiva de Castilla y León
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1. Study Identification

Unique Protocol Identification Number
NCT04929418
Brief Title
Differential Adaptation of Renal Function in Intense Physical Exercise
Official Title
Differential Adaptation of Renal Function in Two Types of Intense Physical Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clínico Universitario de Valladolid
Collaborators
Gerencia Regional de Salud de Castilla y León, Instituto de Investigación Biomédica de Salamanca, Centro Regional de Medicina Deportiva de Castilla y León

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute kidney injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Trial participants will participate sequentially in two tests that involve high intensity physical exercise (10 km continuous running and 1.5 km continuous swimming). Both tests will be separated from each other a minimum of 30 days.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 km continuous running
Arm Type
Other
Arm Description
Participants will perform a test of 10 km coninuous running.
Arm Title
1.5 km swimming
Arm Type
Other
Arm Description
Participants will perform a test of 1.5 km coninuous swimming.
Intervention Type
Other
Intervention Name(s)
10 km continuous running
Intervention Description
Trial participants will perform a 10 km continuous running exercise
Intervention Type
Other
Intervention Name(s)
1.5 km continuous swimming
Intervention Description
Trial participants will perform a 1.5 km continuous swimming exercise.
Primary Outcome Measure Information:
Title
Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels
Time Frame
24 hours
Title
Absolute change in urinary Kidney Injury Molecule-1 (KIM-1) levels
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Absolute change in serum creatinine levels
Time Frame
24 hours
Title
Absolute change in proteinuria
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Clínico Universitario
City
Valladolid
ZIP/Postal Code
47003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Differential Adaptation of Renal Function in Intense Physical Exercise

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