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Completed

NCT Number: NCT02518737

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Biomedical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal test

Other

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Glostrup University Hospital, Copenhagen
  • Rigshospitalet, Denmark
  • The Novo Nordisk Foundation Center for Basic Metabolic Research

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 10, 2015
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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