Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-05-29 @ 12:34 PM
Study NCT ID:
NCT03867656
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2019-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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', 'interventionModelDescription': 'The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CTX', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.'}, {'measure': 'P1NP', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.'}], 'secondaryOutcomes': [{'measure': 'PTH', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'PTH measured in serum'}, {'measure': 'Sclerostin', 'timeFrame': '-10 min to 240 min.', 'description': 'Bone marker.'}, {'measure': 'Glucose', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Measured in serum'}, {'measure': 'Insulin', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Measured in serum'}, {'measure': 'C-peptide', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Measured in serum'}, {'measure': 'GIP', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Glucose-dependent insulinotropic polypeptide measured in plasma.'}, {'measure': 'GLP-2', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Glucagon-like peptide 2 measured in plasma.'}, {'measure': 'Glucagon', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Glucagon measured in plasma'}, {'measure': 'Blood pressure', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Measured before blood sampling'}, {'measure': 'Heart rate', 'timeFrame': '-10 minutes to 240 minutes', 'description': 'Measured before blood sampling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Bone resorption', 'Bone formation', 'CTX', 'P1NP', 'GLP-2', 'GIP', 'Bone turnover', 'Bone remodeling'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age 25 to 70 years old.\n* Type 2 diabetes.\n* In Metformin or sulfonylureas\n\nExclusion Criteria:\n\n* Treatment with other antidiabetics\n* Osteopososis or 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': 'NCT03867656', 'briefTitle': 'Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19', 'orgStudyIdInfo': {'id': 'KS-4-Diabetes-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLP-2', 'description': 'Glucagon-like peptide 2', 'interventionNames': ['Other: GLP-2']}, {'type': 'EXPERIMENTAL', 'label': 'GIP', 'description': 'Glucose-dependent insulinotropic polypeptide', 'interventionNames': ['Other: GIP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'GLP-2', 'type': 'OTHER', 'description': 'GLP-2 injection', 'armGroupLabels': ['GLP-2']}, {'name': 'GIP', 'type': 'OTHER', 'description': 'GIP injection', 'armGroupLabels': ['GIP']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Mette Rosenkilde, 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'}}}}