Bone Disease, MetabolicGINEBRANCT06790225
Glucose-dependent INsulinotropic Polypeptide: Effect on Bone Remodelling and Cell Activity (GINEBRA)
A study testing Glucose-dependent Insulinotropic Polypeptide (GIP) in people with Bone Disease, Metabolic and Diabetes Mellitus, Type 2, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
Glucose-dependent insulinotropic polypeptide (GIP) is released by the intestines in response to food intake and increases insulin secretion. Although short-term (< 3 hours) stimulation with GIP decreases bone resorption in humans, the effect may vanish following continuous administration within 24 hours, at least in… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Disease, Metabolic, Diabetes Mellitus, Type 2, Obesity and Obesity-related Medical Conditions
- What is being tested?
- Glucose-dependent Insulinotropic Polypeptide (GIP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Nov 2025to 17 Sep 2026
- Phase
- Interventional
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- pre-diabetes or diabetes (HbA1c >42mmol/mol)
- BMI >28
- fractures with < 6months
- comorbidities/treatments that may influence bone metabolism or procedures - -- pregnancy
- inability to provide informed concent
Trial locations and contacts
1 site in 1 country.
About this study
Glucose-dependent insulinotropic polypeptide (GIP) is released by the intestines in response to food intake and increases insulin secretion. Although short-term (< 3 hours) stimulation with GIP decreases bone resorption in humans, the effect may vanish following continuous administration within 24 hours, at least in patients with type 1 diabetes. Whether the anti-resorptive effect of GIP can be maintained if the hormone is non-continuously administrated is unclear. As the first GIP receptor (GIPR) agonist, tirzepatide was recently approved for the treatment of obesity and type 2 diabetes in the USA and type 2 diabetes alone in the EU, there is a need to establish knowledge about the long-term effects of GIP on bone health, including if different exposure times to GIP have different skeletal effects.
This project will investigate whether GIP maintains its anti-resorptive potential if given as intermittent compared to continuous infusion in healthy men and women aged 18-40 years. Administration cycles involve intermittent (8 hours daily) and continuous (24 hours daily) injection of GIP for three days each. The effect of GIP will be measured by bone markers in blood samples, as well as in vitro activity and genetic alterations of bone cells (osteoclasts and osteoblasts) using bone marrow aspirates and bone marrow biopsies. Each participant will receive both administration cycles using a crossover design with a 14-28 days washout period between administrations of GIP.
- Conditions
- Bone Disease, Metabolic, Diabetes Mellitus, Type 2, Obesity and Obesity-related Medical Conditions
- Being tested
- Glucose-dependent Insulinotropic Polypeptide (GIP)
- Keywords
- GIP, CTX, P1NP, Glucose-dependent insulinotropic polypeptide, Bone remodelling
- Medical subject headings
- Bone Diseases, Metabolic, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-dependent Insulinotropic Polypeptide (GIP)Other
Recombinant human GIP (1-42)
| Study group | Role | What they receive |
|---|---|---|
| Intermittent then continious | Experimental | The participants that recive the intermittent administration first, followed by the continious Receives: Other: Glucose-dependent Insulinotropic Polypeptide (GIP) |
| Continious then intermittent | Experimental | The participants that recives the continious administration first, follwoed by the intermittent Receives: Other: Glucose-dependent Insulinotropic Polypeptide (GIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of CTX
Serum levels of CTX (bone resorption marker) will be measured prior to, during, and at after the intervention, with both administration methods (continious and intermittent)
Measured: During a three day period. With 14-28 days of washout between the two administration methods
Secondary outcomes (2)
Serum levels of osteocalcin and P1NP
Serum levels of osteocalcin and P1NP (bone formation markers) will be measured prior to, during, and at after the intervention, with both administration methods (continious and intermittent)
Measured: During a three day period. With 14-28 days of washout between the two administration methods
Serum levels of GIP
Serum levels of GIP will be measured prior to, during, and at after the intervention, with both administration methods (continious and intermittent)
Measured: During a three day period. With 14-28 days of washout between the two administration methods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start10 Nov 2025
- Primary completion17 Sep 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Disease, MetabolicStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomized to recive either intermittent ( 8 hours a day) or continious (24 hours a day) GIP infusion for three days. The effect of GIP will be measured by bone markers in blood samples, as well as in vitro activity and genetic alterations of bone cells using bone marrow aspirates and bone marrow biopsies. Each participant will recive both administrations using a crossover design with 14-28 days washout period inbetween.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790225
- Sponsor's protocol ID
- 25/2685
- Acronym
- GINEBRA
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared following GDPR and local data mangament regulation. However data(anonymous) and results will be published once the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose-dependent INsulinotropic Polypeptide: Effect on Bone Remodelling and Cell Activity (GINEBRA)
- ClinicalTrials.gov ID
- NCT06790225
- Acronym / sponsor ID
- GINEBRA / 25/2685
- Conditions
- Bone Disease, Metabolic, Diabetes Mellitus, Type 2, Obesity and Obesity-related Medical Conditions
- Keywords
- GIP, CTX, P1NP, Glucose-dependent insulinotropic polypeptide, Bone remodelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 24 Jan 2025 (actual)
- 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.
Glucose-dependent insulinotropic polypeptide (GIP) is released by the intestines in response to food intake and increases insulin secretion. Although short-term (< 3 hours) stimulation with GIP decreases bone resorption in humans, the effect may vanish following continuous administration within 24 hours, at least in patients with type 1 diabetes. Whether the anti-resorptive effect of GIP can be maintained if the hormone is non-continuously administrated is unclear. As the first GIP receptor (GIPR) agonist, tirzepatide was recently approved for the treatment of obesity and type 2 diabetes in the USA and type 2 diabetes alone in the EU, there is a need to establish knowledge about the long-term effects of GIP on bone health, including if different exposure times to GIP have different skeletal effects.
This project will investigate whether GIP maintains its anti-resorptive potential if given as intermittent compared to continuous infusion in healthy men and women aged 18-40 years. Administration cycles involve intermittent (8 hours daily) and continuous (24 hours daily) injection of GIP for three days each. The effect of GIP will be measured by bone markers in blood samples, as well as in vitro activity and genetic alterations of bone cells (osteoclasts and osteoblasts) using bone marrow aspirates and bone marrow biopsies. Each participant will receive both administration cycles using a crossover design with a 14-28 days washout period between administrations of GIP.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to recive either intermittent ( 8 hours a day) or continious (24 hours a day) GIP infusion for three days. The effect of GIP will be measured by bone markers in blood samples, as well as in vitro activity and genetic alterations of bone cells using bone marrow aspirates and bone marrow biopsies. Each participant will recive both administrations using a crossover design with 14-28 days washout period inbetween.
| Arm | Type | Receives |
|---|---|---|
| Intermittent then continious | Experimental | Other: Glucose-dependent Insulinotropic Polypeptide (GIP)The participants that recive the intermittent administration first, followed by the continious |
| Continious then intermittent | Experimental | Other: Glucose-dependent Insulinotropic Polypeptide (GIP)The participants that recives the continious administration first, follwoed by the intermittent |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (5 listed)
- pre-diabetes or diabetes (HbA1c >42mmol/mol)
- BMI >28
- fractures with < 6months
- comorbidities/treatments that may influence bone metabolism or procedures - -- pregnancy
- inability to provide informed concent
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 |
|---|---|---|
| Glucose-dependent Insulinotropic Polypeptide (GIP)Recombinant human GIP (1-42) | Other | Continious then intermittent, Intermittent then continious |
Primary outcome
Serum levels of CTX
Time frame: During a three day period. With 14-28 days of washout between the two administration methods
Serum levels of CTX (bone resorption marker) will be measured prior to, during, and at after the intervention, with both administration methods (continious and intermittent)
2 secondary outcomes
Serum levels of osteocalcin and P1NP
Time frame: During a three day period. With 14-28 days of washout between the two administration methods
Serum levels of GIP
Time frame: During a three day period. With 14-28 days of washout between the two administration methods
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 1 Oct 2026.
- Individual participant dataSharing planned: No. individual participant data will not be shared following GDPR and local data mangament regulation. However data(anonymous) and results will be published once the study is completed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose-dependent Insulinotropic Polypeptide (GIP) in people with Bone Disease, Metabolic and Diabetes Mellitus, Type 2, run by Esbjerg Hospital - University Hospital of Southern Denmark 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 1 Oct 2026. 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?
Serum levels of CTX (time frame: During a three day period. With 14-28 days of washout between the two administration methods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.