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NCT Number: NCT04929418

Differential Adaptation of Renal Function in 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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario

Valladolid, 47003, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 29.9 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.

Treatment and study plan

10 km continuous running

Other

Trial participants will perform a 10 km continuous running exercise

1.5 km continuous swimming

Other

Trial participants will perform a 1.5 km continuous swimming exercise.

Primary outcomes

  1. Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels

    Time frame: 24 hours

  2. Absolute change in urinary Kidney Injury Molecule-1 (KIM-1) levels

    Time frame: 24 hours

Secondary outcomes

  1. Absolute change in serum creatinine levels

    Time frame: 24 hours

  2. Absolute change in proteinuria

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Hospital Clínico Universitario de Valladolid

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 18, 2021
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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