Bone Blood Flow Regulation, Bone Physiology, Healthy Adult Participants, Peptide Hormones
Conditions
Brief 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.
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.
Interventions
Placebo infusion for comparison of active hormone
OTHERInfusion of GIP(1-42)
Study tool
OTHERInfusion of GLP-2(1-33)
Study tool
OTHERInfusion of pramlintide
Study tool
Sponsors
University of Copenhagen
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Ki in the Femur | 90 minutes | Kinetic modelling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Ki in the lumbar spine | 90 minutes | Kinetic modelling |
| Ki in other bones. | 90 minutes | Kinetic modelling |
| Bone perfusion (K1) | 90 minutes | Kinetic modelling |
| Bone incorporation fraction (K3/K3+K2) | 90 minutes. | Kinetic modelling |
| Mean difference in CTX | 90 minutes. | Bone turnover marker. |
| Mean difference in P1NP | 90 minutes | Bone turnover marker |
| Mean difference in PTH. | 90 minutes. | Bone turnover marker. |
| 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. | — |
Countries
Denmark
Contacts
CONTACTLærke S Gasbjerg, MD, PhD
CONTACTMette G Thomsen, Cand.Scient
Outcome results
None listed