INCREMOS: The Role of Incretins in Bone Remodeling in Humans

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03966261
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 35.7
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Incretins; Osteoporosis; Bone Remodeling; Healthy	Other: blood sample

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: INcrétines et REModelage OSseux
• Actual Study Start Date: Mar 10, 2020
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Outcome Measures

Primary Outcome Measures

1. incretins concentrations before and after a meal in healthy subjects [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Angers	Angers		France

Sponsors and Collaborators

• University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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. pii: JOE-18-0214. doi: 10.1530/JOE-18-0214. [Epub ahead of print]
• 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. Review.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT03966261
• Other Study ID Numbers: 2018-A01632-53
• First Posted: May 29, 2019
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoporosis

Study Results

No Results Posted as of Jul 29, 2022