The Role of Incretins in Bone Remodeling in Humans

NCT03966261 | Terminated

• 1 other identifier: 2018-A01632-53
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Incretins; Osteoporosis; Bone Remodeling; Healthy

Outcome Measures

Primary Outcomes (1)

• incretins concentrations before and after a meal in healthy subjects

  2 years

Interventions

blood sample OTHER

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

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women and men aged from 30 to 70 years without bone patholog nor pathological condition influencing bone remodeling nor treatment influencing bone remodeling

You may qualify if:

• healthy women and men

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, France

Location

Related Publications (3)

• 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: 27423214 BACKGROUND

• 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: 30121578 BACKGROUND

• 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.

  PMID: 29412811 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 29, 2019
• Study Start: March 10, 2020
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)