Differential Adaptation of Renal Function in Intense Physical Exercise

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929418
• Other study ID #: PI-GR-18-914
• Secondary ID: GRS 1732A/18
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: June 2021
• Source: Hospital Clínico Universitario de Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 20, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• 10 km continuous running
Trial participants will perform a 10 km continuous running exercise
• 1.5 km continuous swimming
Trial participants will perform a 1.5 km continuous swimming exercise.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario	Valladolid

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Clínico Universitario de Valladolid	Centro Regional de Medicina Deportiva de Castilla y León, Gerencia Regional de Salud de Castilla y León, Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels		24 hours
Primary	Absolute change in urinary Kidney Injury Molecule-1 (KIM-1) levels		24 hours
Secondary	Absolute change in serum creatinine levels		24 hours
Secondary	Absolute change in proteinuria		24 hours