Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-27 @ 2:36 AM
Study NCT ID:
NCT05181150
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2021-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2021-12-18', 'studyFirstSubmitQcDate': '2021-12-18', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CTX', 'timeFrame': '-10 to 240 minutes', 'description': 'Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.'}], 'secondaryOutcomes': [{'measure': 'P1NP', 'timeFrame': '-10 to 240 minutes', 'description': 'Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.'}, {'measure': 'PTH', 'timeFrame': '-10 to 240 minutes', 'description': 'PTH measured in serum PTH measured in serum'}, {'measure': 'Sclerostin', 'timeFrame': '-10 to 240 minutes', 'description': 'Bone marker'}, {'measure': 'Glucose', 'timeFrame': '-10 to 240 minutes', 'description': 'Measured in serum'}, {'measure': 'Insulin', 'timeFrame': '-10 to 240 minutes', 'description': 'Measured in serum'}, {'measure': 'C-peptide', 'timeFrame': '-10 to 240 minutes', 'description': 'Measured in serum'}, {'measure': 'GIP', 'timeFrame': '-10 to 240 minutes', 'description': 'Glucose-dependent insulinotropic polypeptide measured in plasma'}, {'measure': 'GLP-2', 'timeFrame': '-10 to 240 minutes', 'description': 'Glucagon-like peptide 2 measured in plasma.'}, {'measure': 'Glucagon', 'timeFrame': '-10 to 240 minutes', 'description': 'Glucagon measured in plasma'}, {'measure': 'Blood pressure', 'timeFrame': '-10 to 240 minutes', 'description': 'Measured before blood sampling'}, {'measure': 'Heart rate', 'timeFrame': '-10 to 240 minutes', 'description': 'Measured before blood sampling'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal cord injury', 'GIP', 'GLP-2', 'CTX', 'P1NP', 'Bone resorption', 'Bone formation', 'Bone turnover', 'Bone remodeling'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'Both GLP-2 and GIP reduce bone resorption (measured as CTX) in healthy persons. In this study, we will investigate whether GLP-2 and GIP is reducing CTX in individuals with spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Individuals with spinal cord injury):\n\n* Spinal cord injury resulting in the need of a wheelchair\n* BMI: 16-32 kg/m2\n\nInclusion Criteria (Healthy controls):\n\n* Intact spinal cord\n* Matched on gender, age and BMI to the group with spinal cord injury\n\nExclusion Criteria:\n\n* Treatment with antidiabetics\n* Treatment with anti-resorptive agents\n* Gastrointestinal disease\n* Smoking\n* Long term steroid treatment\n* Weight change more than 3 kg within the last 3 months.\n* Overweight or intestinal surgery'}, 'identificationModule': {'nctId': 'NCT05181150', 'briefTitle': 'Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'CBC-SCI-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal test', 'interventionNames': ['Other: Meal test']}, {'type': 'EXPERIMENTAL', 'label': 'GIP, Glucose-dependent insulinotropic polypeptide', 'interventionNames': ['Other: GIP']}, {'type': 'EXPERIMENTAL', 'label': 'GLP-2, Glucagon-like-peptide-2', 'interventionNames': ['Other: GLP-2']}, {'type': 'EXPERIMENTAL', 'label': 'GIP + GLP-2', 'interventionNames': ['Other: GIP + GLP-2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (saline)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Meal test', 'type': 'OTHER', 'otherNames': ['Nutridrink'], 'description': 'Ingestion of an oral liquid meal (nutridrink), 200 mL.', 'armGroupLabels': ['Meal test']}, {'name': 'GIP', 'type': 'OTHER', 'description': 'Subcutaneous GIP injection.', 'armGroupLabels': ['GIP, Glucose-dependent insulinotropic polypeptide']}, {'name': 'GLP-2', 'type': 'OTHER', 'description': 'Subcutaneous GLP-2 injection.', 'armGroupLabels': ['GLP-2, Glucagon-like-peptide-2']}, {'name': 'GIP + GLP-2', 'type': 'OTHER', 'description': 'Subcutaneous GIP + GLP-2 injection.', 'armGroupLabels': ['GIP + GLP-2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subcutaneous saline injection.', 'armGroupLabels': ['Placebo (saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sten Madsbad', 'role': 'CONTACT', 'email': 'Sten.Madsbad@regionh.dk'}, {'name': 'Charlotte B Christiansen', 'role': 'CONTACT', 'email': 'cbchristiansen@sund.ku.dk'}], 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Charlotte B Christiansen, PhD', 'role': 'CONTACT', 'email': 'cbchristiansen@sund.ku.dk', 'phone': '+45 22459802'}, {'name': 'Kirsa Skov-Jeppesen, PhD', 'role': 'CONTACT', 'email': 'kirsa@sund.ku.dk', 'phone': '+45 26818619'}], 'overallOfficials': [{'name': 'Mette M Rosenkilde, Prof., MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hvidovre University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Kirsa Skov-Jeppesen', 'investigatorAffiliation': 'University of Copenhagen'}}}}