Clinical trial NCT04929418: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
Collaborators: name: Gerencia Regional de Salud de Castilla y Leon
name: Instituto de Investigación Biomédica de Salamanca
name: Centro Regional de Medicina Deportiva de Castilla y León
First posted: 2021-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels
timeFrame: 24 hours
measure: Absolute change in urinary Kidney Injury Molecule-1 (KIM-1) levels
timeFrame: 24 hours
Secondary outcomes:
measure: Absolute change in serum creatinine levels
timeFrame: 24 hours
measure: Absolute change in proteinuria
timeFrame: 24 hours
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario
Study officials:
References: