The Role of Incretins in Bone Remodeling in Humans

NCT ID: NCT03966261

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2022-05-02

Brief Summary

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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.

Detailed Description

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Conditions

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Incretins Osteoporosis Bone Remodeling Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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blood sample

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Angers

Angers, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 27423214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30121578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29412811 (View on PubMed)

Other Identifiers

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2018-A01632-53

Identifier Type: -

Identifier Source: org_study_id

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