Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02712658
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2015-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of K+ and Ca2+ in Development of Muscle Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013726', 'term': 'Terbutaline'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-29', 'studyFirstSubmitDate': '2015-10-11', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in time to fatigue during knee-extensor exercise', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Skeletal Muscle Fatigue in Humans']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle fatigue in trained young men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physical active healthy men\n* aged 18-40 years\n\nExclusion Criteria:\n\n* smokers\n* allergy towards terbutaline\n* chronic disease'}, 'identificationModule': {'nctId': 'NCT02712658', 'briefTitle': 'Role of K+ and Ca2+ in Development of Muscle Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'orgStudyIdInfo': {'id': 'MIK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'terbutaline', 'description': 'terbutaline is administered by injection (0.25-0.5 mg Bricanyl, AstraZeneca diluted in 9 ml isotonic saline)', 'interventionNames': ['Drug: Terbutaline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo is administered as isotonic saline (10 ml)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Terbutaline', 'type': 'DRUG', 'description': 'K+ transport and Ca2+ release and uptake function are stimulated by administration of terbutaline', 'armGroupLabels': ['terbutaline']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Nutrition, Exercise and Sports', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post.Doc', 'investigatorFullName': 'Morten Nielsen', 'investigatorAffiliation': 'University of Copenhagen'}}}}