Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-02 @ 7:38 AM
Study NCT ID:
NCT05746650
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2023-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}, {'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle', 'timeFrame': '2 years', 'description': 'Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue'}], 'secondaryOutcomes': [{'measure': 'Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone', 'timeFrame': '2 years', 'description': 'Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue'}, {'measure': 'Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue', 'timeFrame': '2 years', 'description': 'Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins'}, {'measure': 'Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone', 'timeFrame': '2 years', 'description': 'Dynamic proteome profiling fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in single proteins'}, {'measure': 'Tendon tissue synthesis from injured muscle vs. control muscle', 'timeFrame': '2 years', 'description': 'FSR based on D2O intake and D-alanine label in tissue'}, {'measure': 'Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone', 'timeFrame': '2 years', 'description': 'Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue'}, {'measure': 'Difference in muscle protein synthesis in regenerating vs. control muscle, myotendinous junction, and tendon tissue', 'timeFrame': '2 years', 'description': 'Fractional synthesis rates based on D2O (deuterated water) intake and deuterium labelled alanine in tissue'}, {'measure': 'Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone', 'timeFrame': '2 years', 'description': 'Histochemical staining of muscle cross sections'}, {'measure': 'Mechanical properties of tissue with and without growth hormone', 'timeFrame': '2 years', 'description': 'Ex vivo mechanical stress test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Injury']}, 'descriptionModule': {'briefSummary': 'The study is a 2-week human study where 40 patients who are scheduled to undergo reconstructive knee surgery are randomized to administration of GH or placebo following or without neuromuscular electrical stimulation of hamstring muscles.The overall aim is to determine, the role of muscle connective tissue protein synthesis in muscle injury and repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women scheduled to undergo reconstructive knee surgery\n* BMI 18-35\n\nExclusion Criteria:\n\n* Former or current use of growth hormone or anabolic steroids\n* Use of corticosteroids in the past 3 months\n* Use of any medication known to affect muscle or tendon turnover\n* Former participation in a study using deuterated water\n* Chronic diseases'}, 'identificationModule': {'nctId': 'NCT05746650', 'acronym': 'GH-MTJ', 'briefTitle': 'Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury', 'orgStudyIdInfo': {'id': 'BBH158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1) Electrical stimulation + growth hormone', 'description': 'One bout of electrical stimulation with 200 eccentric contractions. This is followed by daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.', 'interventionNames': ['Procedure: Electrical stimulation', 'Drug: Growth hormone (somatropin)']}, {'type': 'EXPERIMENTAL', 'label': '2) Electrical stimulation', 'description': 'One bout of electrical stimulation with 200 eccentric contractions', 'interventionNames': ['Procedure: Electrical stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3) Growth hormone', 'description': 'Daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.', 'interventionNames': ['Drug: Growth hormone (somatropin)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4) Control', 'description': 'No intervention', 'interventionNames': ['Other: Control (No electrical stimulation, nor growth hormone)']}], 'interventions': [{'name': 'Electrical stimulation', 'type': 'PROCEDURE', 'description': 'Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles', 'armGroupLabels': ['1) Electrical stimulation + growth hormone', '2) Electrical stimulation']}, {'name': 'Growth hormone (somatropin)', 'type': 'DRUG', 'description': 'Daily injection of growth hormone', 'armGroupLabels': ['1) Electrical stimulation + growth hormone', '3) Growth hormone']}, {'name': 'Control (No electrical stimulation, nor growth hormone)', 'type': 'OTHER', 'description': 'No electrical stimulation, nor growth hormone', 'armGroupLabels': ['4) Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Grith Stougaard Højfeldt, PhD', 'role': 'CONTACT', 'email': 'grith.stougaard.hoejfeldt@regionh.dk', 'phone': '+4561651061'}], 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Grith Stougaard Højfeldt, PhD', 'role': 'CONTACT', 'email': 'grith.stougaard.hoejfeldt@regionh.dk', 'phone': '+45 61651061'}], 'overallOfficials': [{'name': 'Grith Højfeldt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Sports Medicine, Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Grith Højfeldt', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}