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

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ClinicalTrials.gov Identifier: NCT02518737
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : July 29, 2016
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Glostrup University Hospital, Copenhagen
The Novo Nordisk Foundation Center for Basic Metabolic Research
Information provided by (Responsible Party):
Bolette Hartmann, University of Copenhagen

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.


Condition or disease Intervention/treatment
Bone Remodeling Other: Meal Test

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Examination of the Postprandial Bone Remodeling in Persons With Reduced Activity of the Receptor for the Enteric Hormone Glucose-dependent Insulinotropic Polypeptide
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. CTx [ Time Frame: 7, 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes after intake of the meal test. ]
    CTx is a biomarker of bone resorption.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The groups will be recruited from the Helbred2006 cohort, Glostrup Hospital, Denmark.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518737


Locations
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Denmark
Department of Biomedical Sciences, University of Copenhagen
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Rigshospitalet, Denmark
Glostrup University Hospital, Copenhagen
The Novo Nordisk Foundation Center for Basic Metabolic Research
Investigators
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Principal Investigator: Bolette Hartmann, PhD University of Copenhagen
Publications:
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Responsible Party: Bolette Hartmann, PhD, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02518737    
Other Study ID Numbers: GRD
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by Bolette Hartmann, University of Copenhagen:
Glucose-dependent Insulinotropic Polypeptide
Receptor Deficiency