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NCT Number: NCT07679516

Postprandial Regulation of Bone Perfusion in Healthy Individuals

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.

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Key information

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 25-50 years.
  • BMI between 18.5-30 kg/m2.
  • Normal gait.
  • Premenopausal (if female).
  • Informed consent.

Exclusion criteria

  • 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).
  • 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)

Treatment and study plan

isotonic saline infusion

Other

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 pramlintide

Other

Study tool

Primary outcomes

  1. Median Ki in the Femur

    Time frame: 90 minutes

    Kinetic modelling

Secondary outcomes

  1. Median Ki in the lumbar spine

    Time frame: 90 minutes

    Kinetic modelling

  2. Ki in other bones.

    Time frame: 90 minutes

    Kinetic modelling

  3. Bone perfusion (K1)

    Time frame: 90 minutes

    Kinetic modelling

  4. Bone incorporation fraction (K3/K3+K2)

    Time frame: 90 minutes.

    Kinetic modelling

  5. Mean difference in CTX

    Time frame: 90 minutes.

    Bone turnover marker.

  6. Mean difference in P1NP

    Time frame: 90 minutes

    Bone turnover marker

  7. Mean difference in PTH.

    Time frame: 90 minutes.

    Bone turnover marker.

  8. Mean difference in GIP(1-42)

    Time frame: 90 minutes.

  9. Mean difference in GLP-2(1-33)

    Time frame: 90 minutes.

  10. Mean difference in pramlintide

    Time frame: 90 minutes.

  11. Mean difference in blood glucose

    Time frame: 90 minutes.

  12. Mean difference in C-peptide

    Time frame: 90 minutes.

Other outcomes

  1. Mean and max SUV (standardized uptake values)

    Time frame: 90 minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Lærke S Gasbjerg, MD, PhD

CONTACT

[email protected]

+4525346894

Mette G Thomsen, Cand.Scient

CONTACT

[email protected]

+4560624598

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Acronym: GA-27

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 1, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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