Healthy Adult ParticipantsGA-27NCT07679516
Postprandial Regulation of Bone Perfusion in Healthy Individuals
A study testing isotonic saline infusion, Infusion of GIP(1-42) and Infusion of GLP-2(1-33) in people with Healthy Adult Participants and Bone Physiology, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to learn whether certain natural hormones - Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2, (GLP-2), and amylin - affect blood flow to the bones. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Bone Physiology, Bone Blood Flow Regulation
- What is being tested?
- isotonic saline infusion, Infusion of GIP(1-42) and Infusion of GLP-2(1-33)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Jul 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25-50 years.
- BMI between 18.5-30 kg/m2.
- Normal gait.
- Premenopausal (if female).
- Informed consent.
Who cannot join
- Bone disease incl. confirmed osteopenia.
- Fracture within the last 6 months at the time of inclusion.
- Amputation or congenital defect of extremities.
- HbA1c>41.9 mmol/mol and/or diagnosed type 1 or type 2 diabetes.
- Any ongoing or prior medication that the investigator evaluates could interfere with the endpoints of the study (e.g. glucocorticoids or other medications that may compromise bone health).
- Pregnancy or breastfeeding (or plans thereof within the study duration).
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- Not using effective hormonal contraceptives or an intra uterine device within study duration (e.g. oral contraceptives, transdermal patch, vaginal ring, Depo-Provera injections, Nexplanon implant).
- Ongoing or prior alcohol abuse (defined per ICD-10 classification for alcohol dependence syndrome, F10.21) or daily alcohol intake
- Use of any illicit substance or narcotics within three months of inclusion, including within study duration.
- Any physical or psychological condition that the investigator evaluates would interfere with trial participation.
- Recent (three months prior to inclusion), ongoing or planned weight loss within study duration (weight loss defined as exceeding -5% bodyweight, or intentional hypocaloric dieting)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Rigshospitalet
Copenhagen
Mette G Thomsen, Cand.scient, +4560624598, mette.grodal@sund.ku.dk
About this study
The goal of this clinical trial is to learn whether certain natural hormones - Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2, (GLP-2), and amylin - affect blood flow to the bones.
Read the detailed description
In this study, participants will attend four study visits. At each visit they will be given infusions with either one of these hormones (GIP, GLP-2, pramlintide (a drug that mimics the natural hormone amylin)) or a placebo infusion (salt water). At the same time, participants will undergo a PET/CT scan where they will be administered a bone tracer (sodium fluoride), to visualize bone blood flow and activity. Participants do not know whether they are given active hormone or placebo infusion.
- Being tested
- isotonic saline infusion, Infusion of GIP(1-42), Infusion of GLP-2(1-33), Infusion of pramlintide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotonic saline infusionOther
Placebo infusion for comparison of active hormone
Infusion of GIP(1-42)Other
Study tool
Infusion of GLP-2(1-33)Other
Study tool
Infusion of pramlintideOther
Study tool
| Study group | Role | What they receive |
|---|---|---|
| Isotonic saline | Placebo comparator | Saltwater infusion in a peripheral vein Receives: Other: isotonic saline infusion |
| GIP(1-42) | Active comparator | Infusion of the native hormone GIP(1-42) in a peripheral vein Receives: Other: Infusion of GIP(1-42) |
| GLP-2(1-33) | Active comparator | Infusion of the native hormone GLP-2(1-33) in a peripheral vein Receives: Other: Infusion of GLP-2(1-33) |
| Pramlintide | Active comparator | Infusion of pramlintide (amylin analogue) in a peripheral vein Receives: Other: Infusion of pramlintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Ki in the Femur
Kinetic modelling
Measured: 90 minutes
Secondary outcomes (12)
Median Ki in the lumbar spine
Kinetic modelling
Measured: 90 minutes
Ki in other bones.
Kinetic modelling
Measured: 90 minutes
Bone perfusion (K1)
Kinetic modelling
Measured: 90 minutes
Bone incorporation fraction (K3/K3+K2)
Kinetic modelling
Measured: 90 minutes.
Mean difference in CTX
Bone turnover marker.
Measured: 90 minutes.
Mean difference in P1NP
Bone turnover marker
Measured: 90 minutes
Mean difference in PTH.
Bone turnover marker.
Measured: 90 minutes.
Mean difference in GIP(1-42)
Measured: 90 minutes.
Mean difference in GLP-2(1-33)
Measured: 90 minutes.
Mean difference in pramlintide
Measured: 90 minutes.
Mean difference in blood glucose
Measured: 90 minutes.
Mean difference in C-peptide
Measured: 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start19 Jul 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679516
- Sponsor's protocol ID
- GA-27-1
- Acronym
- GA-27
- Status last verified
- May 2026
- First submitted
- 25 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share upon request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Regulation of Bone Perfusion in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07679516
- Acronym / sponsor ID
- GA-27 / GA-27-1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 19 Jul 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 1 Jul 2026 (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.
The goal of this clinical trial is to learn whether certain natural hormones - Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2, (GLP-2), and amylin - affect blood flow to the bones.
Detailed description
In this study, participants will attend four study visits. At each visit they will be given infusions with either one of these hormones (GIP, GLP-2, pramlintide (a drug that mimics the natural hormone amylin)) or a placebo infusion (salt water). At the same time, participants will undergo a PET/CT scan where they will be administered a bone tracer (sodium fluoride), to visualize bone blood flow and activity. Participants do not know whether they are given active hormone or placebo infusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Isotonic saline | Placebo comparator | Other: isotonic saline infusionSaltwater infusion in a peripheral vein |
| GIP(1-42) | Active comparator | Other: Infusion of GIP(1-42)Infusion of the native hormone GIP(1-42) in a peripheral vein |
| GLP-2(1-33) | Active comparator | Other: Infusion of GLP-2(1-33)Infusion of the native hormone GLP-2(1-33) in a peripheral vein |
| Pramlintide | Active comparator | Other: Infusion of pramlintideInfusion of pramlintide (amylin analogue) in a peripheral vein |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 25-50 years.
- BMI between 18.5-30 kg/m2.
- Normal gait.
- Premenopausal (if female).
- Informed consent.
Key exclusion criteria (11 listed)
- Bone disease incl. confirmed osteopenia.
- Fracture within the last 6 months at the time of inclusion.
- Amputation or congenital defect of extremities.
- HbA1c>41.9 mmol/mol and/or diagnosed type 1 or type 2 diabetes.
- Any ongoing or prior medication that the investigator evaluates could interfere with the endpoints of the study (e.g. glucocorticoids or other medications that may compromise bone health).
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 |
|---|---|---|
| isotonic saline infusionPlacebo infusion for comparison of active hormone | Other | Isotonic saline |
| Infusion of GIP(1-42)Study tool | Other | GIP(1-42) |
| Infusion of GLP-2(1-33)Study tool | Other | GLP-2(1-33) |
| Infusion of pramlintideStudy tool | Other | Pramlintide |
Primary outcome
Median Ki in the Femur
Time frame: 90 minutes
Kinetic modelling
12 secondary outcomes
Median Ki in the lumbar spine
Time frame: 90 minutes
Ki in other bones.
Time frame: 90 minutes
Bone perfusion (K1)
Time frame: 90 minutes
Bone incorporation fraction (K3/K3+K2)
Time frame: 90 minutes.
Mean difference in CTX
Time frame: 90 minutes.
Mean difference in P1NP
Time frame: 90 minutes
Mean difference in PTH.
Time frame: 90 minutes.
Mean difference in GIP(1-42)
Time frame: 90 minutes.
Mean difference in GLP-2(1-33)
Time frame: 90 minutes.
Mean difference in pramlintide
Time frame: 90 minutes.
Mean difference in blood glucose
Time frame: 90 minutes.
Mean difference in C-peptide
Time frame: 90 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. Will share upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isotonic saline infusion, Infusion of GIP(1-42) and Infusion of GLP-2(1-33) in people with Healthy Adult Participants and Bone Physiology, 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 9 Jul 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lærke S Gasbjerg, MD, PhD (+4525346894, lsg@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Ki in the Femur (time frame: 90 minutes). 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 9 Jul 2026.