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Postprandial Regulation of Bone Perfusion in Healthy Individuals
Condition(s) studied
Healthy Adult ParticipantsBone PhysiologyBone Blood Flow RegulationPeptide Hormones
Investigational drug(s) / intervention(s)
isotonic saline infusionInfusion of GIP(1-42)Infusion of GLP-2(1-33)Infusion of pramlintide
isotonic saline infusion: Placebo infusion for comparison of active hormone
Infusion of GIP(1-42): Study tool
Infusion of GLP-2(1-33): Study tool
Infusion of pramlintide: Study tool
Study 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.
Eligibility
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)
Primary outcome measure(s)
- Median Ki in the Femur — 90 minutes
Kinetic modelling
Trial sites (1)
| Facility | City | Region | Status |
| Rigshospitalet |
Copenhagen |
Denmark |
|
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