Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 4:23 PM
Study NCT ID:
NCT03573934
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2018-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Hormones and Bone Remodeling in Humans (KS-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'Before blood sampling'}, {'measure': 'Blood pressure', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'Before blood sampling'}], 'primaryOutcomes': [{'measure': 'Bone resorption', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'C-terminal telopeptide (CTX) is a marker of bone resorption. Measured in serum.'}, {'measure': 'Bone formation', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'P1NP is a marker of bone formation. Measured in serum.'}], 'secondaryOutcomes': [{'measure': 'Parathyroid hormone', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'PTH is a bone marker'}, {'measure': 'Calcium', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'Measured in serum.'}, {'measure': 'GIP', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'Intact and total GIP.'}, {'measure': 'GLP-2', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'Intact GLP-2'}, {'measure': 'Glucose', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'Measured in serum.'}, {'measure': 'Insulin', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'Measured in serum.'}, {'measure': 'C-peptide', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'Measured in serum.'}, {'measure': 'Sclerostin', 'timeFrame': 'From -10 minutes to 240 minutes.', 'description': 'Bone marker.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Effects of GLP-2 and GIP on bone remodeling in healthy young men.', 'detailedDescription': 'We will investigate acute effects of GLP-2 and GIP on bone remodeling in healthy young men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge between 20 and 40 years old Caucasian Healthy BMI between 18.5 and 24.9 kg/m2.\n\nExclusion Criteria:\n\nChronic disease Smoking Medication Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb\\<8,0 mmol/L Decreased renal function.'}, 'identificationModule': {'nctId': 'NCT03573934', 'acronym': 'KS-2', 'briefTitle': 'Gut Hormones and Bone Remodeling in Humans (KS-2)', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Investigation of GLP-2 Mechanism of Action (KS-2)', 'orgStudyIdInfo': {'id': 'UCHP-KS-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLP-2', 'description': 'Glucagon-Like Peptide-2 (GLP-2) injection', 'interventionNames': ['Other: GLP-2']}, {'type': 'EXPERIMENTAL', 'label': 'GIP', 'description': 'Glucose-dependent Insulinotropic polypeptide (GIP) injection', 'interventionNames': ['Other: GIP']}, {'type': 'EXPERIMENTAL', 'label': 'GLP-2+GIP', 'description': 'GLP-2+GIP injection', 'interventionNames': ['Other: GLP-2+GIP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo injection', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'GLP-2', 'type': 'OTHER', 'description': 'GLP-2', 'armGroupLabels': ['GLP-2']}, {'name': 'GIP', 'type': 'OTHER', 'description': 'GIP', 'armGroupLabels': ['GIP']}, {'name': 'GLP-2+GIP', 'type': 'OTHER', 'description': 'GLP-2+GIP', 'armGroupLabels': ['GLP-2+GIP']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}