Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-28 @ 1:09 PM
Study NCT ID:
NCT03966261
Status:
TERMINATED
Last Update Posted:
2024-01-11
First Post:
2019-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Incretins in Bone Remodeling in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No more inclusion needed for primary critera analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2019-05-27', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incretins concentrations before and after a meal in healthy subjects', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Incretins', 'Osteoporosis', 'Bone Remodeling', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '27423214', 'type': 'BACKGROUND', 'citation': 'Mabilleau G. Interplay between bone and incretin hormones: A review. Morphologie. 2017 Mar;101(332):9-18. doi: 10.1016/j.morpho.2016.06.004. Epub 2016 Aug 8.'}, {'pmid': '30121578', 'type': 'BACKGROUND', 'citation': 'Mabilleau G, Gobron B, Mieczkowska A, Perrot R, Chappard D. Efficacy of targeting bone-specific GIP receptor in ovariectomy-induced bone loss. J Endocrinol. 2018 Nov;239(2):215-227. doi: 10.1530/JOE-18-0214.'}, {'pmid': '29412811', 'type': 'BACKGROUND', 'citation': 'Mabilleau G, Gobron B, Bouvard B, Chappard D. Incretin-based therapy for the treatment of bone fragility in diabetes mellitus. Peptides. 2018 Feb;100:108-113. doi: 10.1016/j.peptides.2017.12.008.'}]}, 'descriptionModule': {'briefSummary': 'The role of incretins (GIP and GLP-1) on cells and bone tissue has been shown in cellular and animal studies. In humans, the role of these hormones is mainly studied in the pathophysiology of diabetes, their effect on bone is unknown. The serum incretin concentration is low and increases rapidly after a meal. This increase is brief, incretins being rapidly degraded by dipeptidylpeptidase 4 (DPP-4). The dosage of these hormones is complex and the basal "normal" serum concentrations and after feeding in healthy subjects are unknown. Before any study on the effect of incretins on bone remodeling in humans, it is necessary to establish physiological concentrations of incretins in healthy subjects.\n\nThe aim of this study is to estimate physiological concentrations of incretins in healthy subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy women and men aged from 30 to 70 years without bone patholog nor pathological condition influencing bone remodeling nor treatment influencing bone remodeling', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy women and men\n\nExclusion Criteria:\n\n* known osteoporosis\n* osteoporotic fracture\n* tobacco\n* alcohol : \\> 2 glasses/day\n* type 1 and type 2 diabetes\n* BMI \\< 19kg/m² or \\> 30kg/m²\n* heart failure, kidney failure\n* cancer\n* bariatric surgery\n* graft\n* cirrhosis\n* use in the past year : bisphosphonate, denosumab, raloxifene, teriparatide, oral or IV glucocorticoid during 3 months or more'}, 'identificationModule': {'nctId': 'NCT03966261', 'acronym': 'INCREMOS', 'briefTitle': 'The Role of Incretins in Bone Remodeling in Humans', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'INcrétines et REModelage OSseux', 'orgStudyIdInfo': {'id': '2018-A01632-53'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood sample', 'type': 'OTHER', 'description': 'we perform blood sample in healthy subject before and after a meal to measure incretins concentration'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}