Examination of the Postprandial Bone Remodeling in Persons With Reduced GIP-Receptor Activity

Bone Remodeling Clinical Trial

Official title:

Examination of the Postprandial Bone Remodeling in Persons With Reduced Activity of the Receptor for the Enteric Hormone Glucose-dependent Insulinotropic Polypeptide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518737
• Other study ID #: GRD
• Status: Completed
• Phase: N/A
• First received: August 5, 2015
• Last updated: July 27, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The bone tissue of the human adult body is in a constant process of break-down (resorption) and rebuilding (formation), a process called bone remodeling. The extent to which bone remodeling happens varies during the day, especially a decrease in the bone resorption is observed after eating.

The overall purpose of this study is to examine the possible role of the hormone Glucose-dependent Insulinotropic Polypeptide (GIP) in Bone Remodeling. GIP is released from cells in the gut after eating, and previous studies have shown an effect of GIP on bone tissue. In addition, it has been observed that the risk of bone fracture is 60% higher in women with a mutation in the GIP receptor, when compared to women with a normal functioning GIP receptor.

In the present study humans with a mutation in their GIP receptor is compared to humans with a normal functioning GIP receptor. The study population will be examined during a meal stimulation test, where blood will be sampled regularly. The blood samples will be examined for markers of bone resorption among other markers of bone remodeling, GIP and other gut hormones.

The hypothesis for the present study is that GIP secreted after meal ingestion inhibits bone resorption. Thus it is expected that the decrease in resorption is less pronounced in the humans carrying the GIP-receptor mutation, compared to humans with a normal functioning GIP receptor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Verified mutation (Glu354Gln) of the GIP-receptor

Exclusion Criteria:

• Type 2 diabetes

• Pregnancy

• Previous long-lasting treatment with steroids

• On-going steroid treatment (with the exception of inhalation-steroids)

• Osteoporosis

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bone Remodeling

Intervention

Other:
• Meal Test

Locations

Country	Name	City	State
Denmark	Department of Biomedical Sciences, University of Copenhagen	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Glostrup University Hospital, Copenhagen, Novo Nordisk Foundation Center for Basic Metabolic Research, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

Nielsen HK, Brixen K, Kassem M, Christensen SE, Mosekilde L. Diurnal rhythm in serum osteocalcin: relation with sleep, growth hormone, and PTH(1-84). Calcif Tissue Int. 1991 Dec;49(6):373-7. — View Citation

Nissen A, Christensen M, Knop FK, Vilsbøll T, Holst JJ, Hartmann B. Glucose-dependent insulinotropic polypeptide inhibits bone resorption in humans. J Clin Endocrinol Metab. 2014 Nov;99(11):E2325-9. doi: 10.1210/jc.2014-2547. Epub 2014 Aug 21. — View Citation

Qvist P, Christgau S, Pedersen BJ, Schlemmer A, Christiansen C. Circadian variation in the serum concentration of C-terminal telopeptide of type I collagen (serum CTx): effects of gender, age, menopausal status, posture, daylight, serum cortisol, and fasting. Bone. 2002 Jul;31(1):57-61. — View Citation

Torekov SS, Harsløf T, Rejnmark L, Eiken P, Jensen JB, Herman AP, Hansen T, Pedersen O, Holst JJ, Langdahl BL. A functional amino acid substitution in the glucose-dependent insulinotropic polypeptide receptor (GIPR) gene is associated with lower bone mineral density and increased fracture risk. J Clin Endocrinol Metab. 2014 Apr;99(4):E729-33. doi: 10.1210/jc.2013-3766. Epub 2014 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTx	CTx is a biomarker of bone resorption.	7, 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes after intake of the meal test.	No