Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-04 @ 9:27 PM
Study NCT ID:
NCT03317704
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2017-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regulation of Metabolism and Ion Handling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2017-10-20', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Femoral venous plasma K+', 'timeFrame': 'Change from before (baseline) to after 6 weeks of training (Week 6)', 'description': 'Femoral venous plasma K+ in mmol/L during knee-extensor exercise'}, {'measure': 'Femoral venous lactate', 'timeFrame': 'Change from before (baseline) to after 6 weeks of training (Week 6)', 'description': 'Femoral venous lactate in mmol/L during knee-extensor exercise'}, {'measure': 'Muscle Na+/K+-ATPase subunit content', 'timeFrame': 'Change from before (baseline) to after 6 weeks of training (Week 6)', 'description': 'Muscle Na+/K+-ATPase subunit content from vastus lateralis biopsies'}, {'measure': 'Muscle mitochondrial respiration', 'timeFrame': 'Change from before (baseline) to after 6 weeks of training (Week 6)', 'description': 'Muscle mitochondrial respiration by high resolution respirometry (flux per mg muscle) from vastus lateralis biopsies'}, {'measure': 'Muscle mitochondrial content', 'timeFrame': 'Change from before (baseline) to after 6 weeks of training (Week 6)', 'description': 'Muscle mitochondrial content of citrate synthase from vastus lateralis biopsies'}], 'primaryOutcomes': [{'measure': 'Quadriceps endurance', 'timeFrame': 'Change from before (baseline) to after 6 weeks of training (Week 6)', 'description': 'Time to exhaustion during knee-extensor exercise'}], 'secondaryOutcomes': [{'measure': 'K+ release', 'timeFrame': 'Change from before (baseline) to after 6 weeks of training (Week 6)', 'description': 'Net leg K+ release in mmol/min during knee-extensor exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study investigates the relation between ion-handling (K+) and fatigue development during exercise. Before and after a 6-week period of high intensity interval training, performance and ion-handling is assessed in young adults. In addition, mitochondrial function is examined.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men\n* 45-55 ml/kg/min\n* BMI 19-26 kg/m2\n* Normal ECG (assessed by MD)\n\nExclusion Criteria:\n\n* Allergic to n-acetylcystine (NAC) or digoxin\n* Severe side effects from NAC or digoxin\n* Chronic diseases (assessed by MD to be a potential hazard or to interfere with outcome measures)'}, 'identificationModule': {'nctId': 'NCT03317704', 'briefTitle': 'Regulation of Metabolism and Ion Handling', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Regulation of Metabolism and Ion Handling - Effect of High Intensity Training and NAC-infusion in Young Men', 'orgStudyIdInfo': {'id': 'SET-NAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'speed endurance training (SET)', 'description': 'Training 6 weeks 3 times pr. week', 'interventionNames': ['Behavioral: Speed endurance training']}, {'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': 'Asked to continue their usual life style'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'speed endurance training (SET) II', 'description': 'Training 6 weeks 3 times pr. week', 'interventionNames': ['Behavioral: Speed endurance training']}], 'interventions': [{'name': 'Speed endurance training', 'type': 'BEHAVIORAL', 'description': 'Speed endurance training', 'armGroupLabels': ['speed endurance training (SET)', 'speed endurance training (SET) II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morten Hostrup, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}