NCT02518737

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

August 5, 2015

Last Update Submit

July 27, 2016

Conditions

Bone Remodeling

Keywords

Glucose-dependent Insulinotropic PolypeptideReceptor Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

GIP-receptor deficient

Persons with a mutation (Glu354Gln) causing their GIP-receptor to loose function.

Other: Meal Test

Controls

Matched controls, with a normal functioning GIP-receptor.

Other: Meal Test

Interventions

Meal TestOTHER
ControlsGIP-receptor deficient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The groups will be recruited from the Helbred2006 cohort, Glostrup Hospital, Denmark.

You may qualify if:

  • Verified mutation (Glu354Gln) of the GIP-receptor

You may not qualify if:

  • Type 2 diabetes
  • Pregnancy
  • Previous long-lasting treatment with steroids
  • On-going steroid treatment (with the exception of inhalation-steroids)
  • Osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Publications (4)

  • 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. doi: 10.1016/s8756-3282(02)00791-3.

    PMID: 12110413BACKGROUND

  • 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. doi: 10.1007/BF02555845.

    PMID: 1818760BACKGROUND

  • Nissen A, Christensen M, Knop FK, Vilsboll 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.

    PMID: 25144635BACKGROUND

  • Torekov SS, Harslof 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.

    PMID: 24446656BACKGROUND

Study Officials

  • Bolette Hartmann, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 10, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

DK(1)