Differential Adaptation of Renal Function in Intense Physical Exercise

Study Overview
=================
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.

Official Title
-----------------
Differential Adaptation of Renal Function in Two Types of Intense Physical Exercise

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: 10 km continuous running
* Other: 1.5 km continuous swimming


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 10 km continuous running<br>Participants will perform a test of 10 km coninuous running. | Other: 10 km continuous running<br>* Trial participants will perform a 10 km continuous running exercise<br>Other: 1.5 km continuous swimming<br>* Trial participants will perform a 1.5 km continuous swimming exercise.<br>|
| Other: 1.5 km swimming<br>Participants will perform a test of 1.5 km coninuous swimming. | Other: 10 km continuous running<br>* Trial participants will perform a 10 km continuous running exercise<br>Other: 1.5 km continuous swimming<br>* Trial participants will perform a 1.5 km continuous swimming exercise.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in serum creatinine levels |  | 24 hours | 
| Absolute change in proteinuria |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute kidney injury