Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-02 @ 5:40 AM
Study NCT ID:
NCT04136457
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2019-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proteome Remodelling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076663', 'term': 'Endurance Training'}, {'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-10-21', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Skeletal muscle mitochondrial supercomplexes', 'timeFrame': 'Change from baseline at week 6 following endurance and sprint training', 'description': 'Pathway enrichment analysis of mitochondrial supercomplexes'}], 'primaryOutcomes': [{'measure': 'Skeletal muscle proteome signature', 'timeFrame': 'Change from baseline at week 6 or 8 depending on the intervention', 'description': 'Pathway enrichment analysis of the muscle proteome'}, {'measure': 'Anabolic signaling', 'timeFrame': 'Change in anabolic signaling from rest to 1 hour following resistance exercise both at baseline and following 8 weeks of resistance training', 'description': 'Western blotting of proteins related to anabolic signaling'}], 'secondaryOutcomes': [{'measure': 'Skeletal muscle mitochondrial respiration', 'timeFrame': 'Change from baseline at week 6 following endurance and sprint training', 'description': 'High resolution respirometry'}, {'measure': 'Maximal oxygen consumption', 'timeFrame': 'Change from baseline at week 6 following endurance and sprint training', 'description': 'VO2max during incremental exercise'}, {'measure': 'Body composition', 'timeFrame': 'Change from baseline at week 6 or 8 depending on the intervention', 'description': 'Lean and fat mass during dual X-ray absorptiometry'}, {'measure': 'Myonuclei', 'timeFrame': 'Change from baseline at week 8 following resistance training', 'description': 'Immunohistochemistry to determine number of myonuclei'}, {'measure': 'Satellite cells', 'timeFrame': 'Change from baseline at week 8 following resistance training', 'description': 'Immunohistochemistry to determine number of satellite cells'}, {'measure': 'Fiber size', 'timeFrame': 'Change from baseline at week 8 following resistance training', 'description': 'Immunohistochemistry to determine fiber size'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skeletal Muscle Physiology']}, 'referencesModule': {'references': [{'pmid': '40818533', 'type': 'DERIVED', 'citation': 'Kissow J, Jacobsen KJ, Jessen S, Thomsen LB, Quesada JP, Bangsbo J, Deshmukh AS, Hostrup M. Global Proteomics Reveals Distinct Muscle Adaptations to Menstrual Cycle Phase-Based Sprint Interval Training in Endurance-Trained Females. Mol Cell Proteomics. 2025 Oct;24(10):101053. doi: 10.1016/j.mcpro.2025.101053. Epub 2025 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the project is to investigate the proteome signature dynamics and remodelling in human skeletal muscle induced by exercise training'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* VO2max \\> 55 mL/min/kgLM for men and \\> 50 for women (only applicable for endurance and sprint training interventions)\n* BMI \\< 26\n\nExclusion Criteria:\n\n* Chronic disease deemed by the medical doctor to pose a risk or to affect study outcomes\n* smoking\n* Use of prescription medicine deemed by the medical to affect study outcomes\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04136457', 'briefTitle': 'Proteome Remodelling', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Proteome Remodelling and Dynamics in Human Skeletal Muscle: Effect of Training', 'orgStudyIdInfo': {'id': 'MiDy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endurance', 'description': 'Endurance training', 'interventionNames': ['Other: Endurance training']}, {'type': 'EXPERIMENTAL', 'label': 'Resistance', 'description': 'Resistance training', 'interventionNames': ['Other: Resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'Sprint', 'description': 'Sprint training', 'interventionNames': ['Other: Sprint training']}], 'interventions': [{'name': 'Endurance training', 'type': 'OTHER', 'description': 'Subjects perform a period of endurance training', 'armGroupLabels': ['Endurance']}, {'name': 'Resistance training', 'type': 'OTHER', 'description': 'Subjects perform a period of resistance training', 'armGroupLabels': ['Resistance']}, {'name': 'Sprint training', 'type': 'OTHER', 'description': 'Subjects perform a period of sprint training', 'armGroupLabels': ['Sprint']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', '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'}}}}