Bone RemodelingNCT02518737
Examination of the Postprandial Bone Remodeling in Persons With Reduced GIP-Receptor Activity
An observational study of Bone Remodeling, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Remodeling
- What is being tested?
- Meal Test
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The groups will be recruited from the Helbred2006 cohort, Glostrup Hospital, Denmark.
Who may be able to join
- Verified mutation (Glu354Gln) of the GIP-receptor
Who cannot join
- Type 2 diabetes
- Pregnancy
- Previous long-lasting treatment with steroids
- On-going steroid treatment (with the exception of inhalation-steroids)
- Osteoporosis
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Biomedical Sciences, University of Copenhagen
Copenhagen, 2200
About this study
Official title: 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.
Read more
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.
- Conditions
- Bone Remodeling
- Being tested
- Meal Test
- Keywords
- Glucose-dependent Insulinotropic Polypeptide, Receptor Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal TestOther
| Study group | Role | What they receive |
|---|---|---|
| GIP-receptor deficient | Persons with a mutation (Glu354Gln) causing their GIP-receptor to loose function. Receives: Other: Meal Test | |
| Controls | Matched controls, with a normal functioning GIP-receptor. Receives: Other: Meal Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTx
CTx is a biomarker of bone resorption.
Measured: 7, 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes after intake of the meal test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bone RemodelingStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Glostrup University Hospital, Copenhagen, The Novo Nordisk Foundation Center for Basic Metabolic Research
- Responsible party
- Principal investigator, Bolette Hartmann, University of Copenhagen
- Investigators
- Bolette Hartmann, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518737
- Sponsor's protocol ID
- GRD
- Status last verified
- Jul 2016
- First submitted
- 5 Aug 2015
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12110413Nielsen 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.
PubMed 1818760Nissen 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.
PubMed 25144635Torekov 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.
PubMed 24446656
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Postprandial Bone Remodeling in Persons With Reduced Activity of the Receptor for the Enteric Hormone Glucose-dependent Insulinotropic Polypeptide
- ClinicalTrials.gov ID
- NCT02518737
- Acronym / sponsor ID
- GRD
- Conditions
- Bone Remodeling
- Keywords
- Glucose-dependent Insulinotropic Polypeptide, Receptor Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Glostrup University Hospital, Copenhagen, The Novo Nordisk Foundation Center for Basic Metabolic Research
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIP-receptor deficient | – | Other: Meal TestPersons with a mutation (Glu354Gln) causing their GIP-receptor to loose function. |
| Controls | – | Other: Meal TestMatched controls, with a normal functioning GIP-receptor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The groups will be recruited from the Helbred2006 cohort, Glostrup Hospital, Denmark.
Key inclusion criteria (1 listed)
- Verified mutation (Glu354Gln) of the GIP-receptor
Key exclusion criteria (5 listed)
- Type 2 diabetes
- Pregnancy
- Previous long-lasting treatment with steroids
- On-going steroid treatment (with the exception of inhalation-steroids)
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal Test | Other | Controls, GIP-receptor deficient |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Background: PubMed 12110413Qvist 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.
- Background: PubMed 1818760Nielsen 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.
- Background: PubMed 25144635Nissen 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.
- Background: PubMed 24446656Torekov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bolette Hartmann, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Remodeling, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTx (time frame: 7, 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes after intake of the meal test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518737, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.