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

July 27, 2016 updated by: Bolette Hartmann, University of Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • Department of Biomedical Sciences, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7, 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes after intake of the meal test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (ESTIMATE)

August 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GRD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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