Postprandial Regulation of Bone Perfusion in Healthy Individuals

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.

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.

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)