Postprandial Regulation of Bone Perfusion in Healthy Individuals (GA-27)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Participants; Gut Hormones; Bone Blood Flow Regulation; Peptide Hormones; Amylin; Bone Physiology; GLP-2; GIP
• Intervention / Treatment: Other: isotonic saline infusion; Other: Infusion of GIP(1-42); Other: Infusion of GLP-2(1-33); Other: Infusion of pramlintide

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lærke S Gasbjerg, MD, PhD; Phone Number: +4525346894; Email: lsg@sund.ku.dk
• Study Contact Backup: Name: Mette G Thomsen, Cand.scient; Phone Number: +4560624598; Email: mette.grodal@sund.ku.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
    • Contact: Mette G Thomsen, Cand.scient; Phone Number: +4560624598; Email: mette.grodal@sund.ku.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 25-50 years.
2. BMI between 18.5-30 kg/m2.
3. Normal gait.
4. Premenopausal (if female).
5. Informed consent.

Exclusion Criteria:

1. Bone disease incl. confirmed osteopenia.
2. Fracture within the last 6 months at the time of inclusion.
3. Amputation or congenital defect of extremities.
4. HbA1c>41.9 mmol/mol and/or diagnosed type 1 or type 2 diabetes.
5. 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).
6. Pregnancy or breastfeeding (or plans thereof within the study duration).
7. 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).
8. Ongoing or prior alcohol abuse (defined per ICD-10 classification for alcohol dependence syndrome, F10.21) or daily alcohol intake
9. Use of any illicit substance or narcotics within three months of inclusion, including within study duration.
10. Any physical or psychological condition that the investigator evaluates would interfere with trial participation.
11. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Isotonic saline; Saltwater infusion in a peripheral vein	Other: isotonic saline infusion; Placebo infusion for comparison of active hormone
Active Comparator: GIP(1-42); Infusion of the native hormone GIP(1-42) in a peripheral vein	Other: Infusion of GIP(1-42); Study tool
Active Comparator: GLP-2(1-33); Infusion of the native hormone GLP-2(1-33) in a peripheral vein	Other: Infusion of GLP-2(1-33); Study tool
Active Comparator: Pramlintide; Infusion of pramlintide (amylin analogue) in a peripheral vein	Other: Infusion of pramlintide; Study tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Ki in the Femur	Kinetic modelling	90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Ki in the lumbar spine	Kinetic modelling	90 minutes
Ki in other bones.	Kinetic modelling	90 minutes
Bone perfusion (K1)	Kinetic modelling	90 minutes
Bone incorporation fraction (K3/K3+K2)	Kinetic modelling	90 minutes.
Mean difference in CTX	Bone turnover marker.	90 minutes.
Mean difference in P1NP	Bone turnover marker	90 minutes
Mean difference in PTH.	Bone turnover marker.	90 minutes.
Mean difference in GIP(1-42)		90 minutes.
Mean difference in GLP-2(1-33)		90 minutes.
Mean difference in pramlintide		90 minutes.
Mean difference in blood glucose		90 minutes.
Mean difference in C-peptide		90 minutes.

Other Outcome Measures

Outcome Measure	Time Frame
Mean and max SUV (standardized uptake values)	90 minutes.

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): July 19, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GA-27-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No