Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT03565302
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2018-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Beta2-adrenergic Agonism and Muscle Remodelling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Drug exposure', 'timeFrame': 'Day 1-14 and day 49-56', 'description': 'Measured in urine using enantiomeric analysis'}], 'primaryOutcomes': [{'measure': 'Proteome enrichment', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in enrichment (measured in muscle biopsies and assessed using GO annotations)'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': 'Baseline, 2 weeks, 4 weeks and 6 weeks', 'description': 'Change in body composition (measured by dual energy x ray absorptiometry)'}, {'measure': 'Maximal oxygen consumption (VO2max)', 'timeFrame': 'Baseline, 2 weeks, 4 weeks and 6 weeks', 'description': 'Change in VO2max (measured during bike ergometer cycling to exhaustion)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proteome', 'VO2max', 'Muscle function', 'Exercise performance', 'Skeletal muscle', 'Doping', 'Anti-Doping', 'Enantiomeric analysis'], 'conditions': ['Hypertrophy', 'Physiologic Hypertrophy', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate gender-specific adaptations to beta2-adrenoceptor stimulation with selective short- and long-acting beta2-agonist with emphasis on skeletal muscle in relation to performance enhancing effects and anti-doping'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women, aged 18-45 years\n* VO2max \\>55 ml/kg/min for men and \\>50 ml/kg/min for women (± biologic and techinical variation of 5.6% (Katch et al. 1982)\n* Body Mass Index (BMI) \\< 26\n\nExclusion Criteria:\n\n* Chronic user of beta2-agonist or allergy towards study drugs\n* Serious adverse side effects of the used study drug\n* Chronic disease that by the project physician would affect any of the outcomes of the study\n* Smoker\n* Chronic use of prescription medication (other than contraceptives for women)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03565302', 'briefTitle': 'Beta2-adrenergic Agonism and Muscle Remodelling', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Gender-specific Role of the beta2-adrenergic Stimulation With Short- or Long-acting Selective Agonist in Relation to Muscle Remodelling, Function, Performance, and Anti-doping', 'orgStudyIdInfo': {'id': 'FOR/TER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Subjects receive placebo treatment', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Long acting beta2-agonist', 'description': 'Subjects are treated with long-acting beta2-agonist formoterol', 'interventionNames': ['Drug: Formoterol']}, {'type': 'EXPERIMENTAL', 'label': 'Short acting beta2-agonist', 'description': 'Subjects are treated with short-acting beta2-agonist terbutaline', 'interventionNames': ['Drug: Terbutaline']}], 'interventions': [{'name': 'Formoterol', 'type': 'DRUG', 'description': 'Subjects are treated with daily inhalation of formoterol', 'armGroupLabels': ['Long acting beta2-agonist']}, {'name': 'Terbutaline', 'type': 'DRUG', 'description': 'Subjects are treated with daily inhalation of terbutaline', 'armGroupLabels': ['Short acting beta2-agonist']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subjects are treated with placebo', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten Hostrup, PhD', 'role': 'CONTACT', 'email': 'mhostrup@nexs.ku.dk', 'phone': '+4524474785'}], 'facility': 'August Krogh Building', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morten Hostrup, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}