Examination of the Postprandial Bone Remodeling in Person... | NCT02518737

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

NCT02518737

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Jul 29, 2016Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Bone Remodeling

Interventions

Meal Test

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Aug 5, 2015

First Submission Date that Met QC Criteria

Aug 7, 2015

First Posted Date

Aug 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2016

Last Update Posted Date

Jul 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bolette Hartmann, PhD, Associate Professor, University of CopenhagenPrincipal Investigator

Lead Sponsor

University of CopenhagenOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Meal Test	Other		Controls GIP-receptor deficient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bolette Hartmann, PhD	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Biomedical Sciences, University of Copenhagen		Copenhagen		2200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12110413	Background	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.
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