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NCT03966261 Clinical Trial

The Role of Incretins in Bone Remodeling in Humans

Healthy Clinical Trial

— INCREMOS  

Official title:
INcrétines et REModelage OSseux

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03966261
Other study ID # 2018-A01632-53
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 10, 2020
Est. completion date May 2, 2022

Study information
Verified date January 2024
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. The aim of this study is to estimate physiological concentrations of incretins in healthy subject.

Recruitment information / eligibility
Status Terminated
Enrollment 104
Est. completion date May 2, 2022
Est. primary completion date May 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria: - healthy women and men Exclusion Criteria: - known osteoporosis - osteoporotic fracture - tobacco - alcohol : > 2 glasses/day - type 1 and type 2 diabetes - BMI < 19kg/m² or > 30kg/m² - heart failure, kidney failure - cancer - bariatric surgery - graft - cirrhosis - use in the past year : bisphosphonate, denosumab, raloxifene, teriparatide, oral or IV glucocorticoid during 3 months or more

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• blood sample
we perform blood sample in healthy subject before and after a meal to measure incretins concentration

Locations
Country Name City State
France CHU Angers Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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 Aug 18:JOE-18-0214. doi: 10.1530/JOE-18-0214. Online ahead of print. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary incretins concentrations before and after a meal in healthy subjects 2 years
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