Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04929418
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2021-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Differential Adaptation of Renal Function in Intense Physical Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-11', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-06-11', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'Absolute change in serum creatinine levels', 'timeFrame': '24 hours'}, {'measure': 'Absolute change in proteinuria', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute kidney injury'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': '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.\n\nUrinary 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.\n\nThe aim of this study is to carry out an integrative analysis of the development of exercise-associated subclinical acute kidney injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Able to understand the objectives of the study and to provide informed consent.\n* Body mass index between 18.5 and 24.9 kg / m2\n* Active sportsman/woman (defined as previous experience with the planned tests and performing vigorous-intensity aerobic activity at least three times per week).\n\nExclusion Criteria:\n\n* 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.\n* Use of NSAIDs in the 72h prior to the test.\n* Consumption of statins or anabolic steroids.\n* Some kind of major physical injury in the four months prior to the tests.'}, 'identificationModule': {'nctId': 'NCT04929418', 'briefTitle': 'Differential Adaptation of Renal Function in Intense Physical Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clínico Universitario de Valladolid'}, 'officialTitle': 'Differential Adaptation of Renal Function in Two Types of Intense Physical Exercise', 'orgStudyIdInfo': {'id': 'PI-GR-18-914'}, 'secondaryIdInfos': [{'id': 'GRS 1732A/18', 'type': 'OTHER_GRANT', 'domain': 'Gerencia Regional de Salud de Castilla y León'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '10 km continuous running', 'description': 'Participants will perform a test of 10 km coninuous running.', 'interventionNames': ['Other: 10 km continuous running', 'Other: 1.5 km continuous swimming']}, {'type': 'OTHER', 'label': '1.5 km swimming', 'description': 'Participants will perform a test of 1.5 km coninuous swimming.', 'interventionNames': ['Other: 10 km continuous running', 'Other: 1.5 km continuous swimming']}], 'interventions': [{'name': '10 km continuous running', 'type': 'OTHER', 'description': 'Trial participants will perform a 10 km continuous running exercise', 'armGroupLabels': ['1.5 km swimming', '10 km continuous running']}, {'name': '1.5 km continuous swimming', 'type': 'OTHER', 'description': 'Trial participants will perform a 1.5 km continuous swimming exercise.', 'armGroupLabels': ['1.5 km swimming', '10 km continuous running']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clínico Universitario de Valladolid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gerencia Regional de Salud de Castilla y Leon', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Biomédica de Salamanca', 'class': 'OTHER'}, {'name': 'Centro Regional de Medicina Deportiva de Castilla y León', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc, phD', 'investigatorFullName': 'Armando Coca Rojo', 'investigatorAffiliation': 'Hospital Clínico Universitario de Valladolid'}}}}