Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT03728959
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2018-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007011', 'term': 'Hypoparathyroidism'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D019294', 'term': 'Xanthomatosis, Cerebrotendinous'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014973', 'term': 'Xanthomatosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2018-10-31', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '-10 to 240 minutes', 'description': 'Blood pressure (systolic and diastolic) measured before blood sampling'}, {'measure': 'Heart rate', 'timeFrame': '-10 to 240 minutes', 'description': 'Heart rate measured before blood sampling'}], 'primaryOutcomes': [{'measure': 'Serum concentration of C-terminal telopeptide (CTX)', 'timeFrame': '-10 to 240 minutes', 'description': 'Marker of bone resorption, measured in serum'}, {'measure': 'N-terminal propeptide of type 1 procollagen (P1NP)', 'timeFrame': '-10 to 240 minutes', 'description': 'Marker of bone formation, concentration measured in serum'}], 'secondaryOutcomes': [{'measure': 'PTH', 'timeFrame': '-10 to 240 minutes', 'description': 'PTH concentration measured in serum'}, {'measure': 'Glucose-dependent insulinotropic polypeptide (GIP)', 'timeFrame': '-10 to 240 minutes', 'description': 'Gut hormone, concentration measured in plasma'}, {'measure': 'Glucagon-like peptide-2 (GLP-2)', 'timeFrame': '-10 to 240 minutes', 'description': 'Gut hormone, concentration measured in plasma'}, {'measure': 'Glucagon-like peptide-1 (GLP-1)', 'timeFrame': '-10 to 240 minutes', 'description': 'Gut hormone, concentration measured in plasma'}, {'measure': 'Glucose', 'timeFrame': '-10 to 240 minutes', 'description': 'Glucose concentration measured in serum'}, {'measure': 'Insulin', 'timeFrame': '-10 to 240 minutes', 'description': 'Insulin concentration measured in serum'}, {'measure': 'C-peptide', 'timeFrame': '-10 to 240 minutes', 'description': 'C-peptide concentration measured in serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypoparathyroidism', 'Glucose-dependent insulinotropic polypeptide (GIP)', 'Glucagon-like peptide-2 (GLP-2)', 'Bone remodeling', 'Bone resorption', 'Bone formation', 'C-terminal telopeptide (CTX)', 'N-terminal propeptide of type 1 procollagen (P1NP)'], 'conditions': ['Hypoparathyroidism']}, 'descriptionModule': {'briefSummary': 'Hypoparathyroidism (hypoPT) is characterized by low levels of PTH.\n\nIn this study we will test the effects of a liquid meal on the bone remodeling in participants with hypoparathyroidism. Furthermore, we will test the effects of the gut hormones GIP and GLP-2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 76\n* Hypoparathyroidism\n\nExclusion Criteria:\n\n* Diabetes\n* Disease in the gastrointestinal tract\n* Antiosteoporotic drug\n* Long term steroid treatment (within the last 12 months)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03728959', 'acronym': 'KS-4-HypoPT', 'briefTitle': 'Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism.', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism (KS-4-HypoPT).', 'orgStudyIdInfo': {'id': 'KS-4-HypoPT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liquid meal (Nutridrink)', 'description': 'Liquid meal (Nutridrink)', 'interventionNames': ['Other: Liquid meal (Nutridrink)']}, {'type': 'EXPERIMENTAL', 'label': 'GIP', 'description': 'Glucose-dependent insulinotropic polypeptide', 'interventionNames': ['Other: GIP']}, {'type': 'EXPERIMENTAL', 'label': 'GLP-2', 'description': 'Glucagon-like peptide-2', 'interventionNames': ['Other: GLP-2']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo (saline)', 'description': 'Placebo (saline)', 'interventionNames': ['Other: Placebo (saline)']}], 'interventions': [{'name': 'Liquid meal (Nutridrink)', 'type': 'OTHER', 'description': 'Liquid meal ingested over 1 minute.', 'armGroupLabels': ['Liquid meal (Nutridrink)']}, {'name': 'GIP', 'type': 'OTHER', 'description': 'Subcutaneous injected GIP', 'armGroupLabels': ['GIP']}, {'name': 'GLP-2', 'type': 'OTHER', 'description': 'Subcutaneous injected GLP-2', 'armGroupLabels': ['GLP-2']}, {'name': 'Placebo (saline)', 'type': 'OTHER', 'description': 'Subcutaneous injected Placebo (saline)', 'armGroupLabels': ['Placebo (saline)']}]}, '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': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hvidovre University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator. Cand.pharm., ph.d. student', 'investigatorFullName': 'Kirsa Skov-Jeppesen', 'investigatorAffiliation': 'University of Copenhagen'}}}}