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Not yet recruiting NCT07679516

Postprandial Regulation of Bone Perfusion in Healthy Individuals

No phase Interventional Healthy Adult Participants Bone Physiology Bone Blood Flow Regulation Peptide Hormones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: isotonic saline infusion, Infusion of GIP(1-42), Infusion of GLP-2(1-33), Infusion of pramlintide.
Who it may be relevant to
Registry conditions: Healthy Adult Participants, Bone Physiology, Bone Blood Flow Regulation, Peptide Hormones. Basic parameters: 25 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Other isotonic saline infusion
    Placebo infusion for comparison of active hormone
  • Other Infusion of GIP(1-42)
    Study tool
  • Other Infusion of GLP-2(1-33)
    Study tool
  • Other Infusion of pramlintide
    Study tool

Primary outcome measures

  • Median Ki in the Femur [Time frame: 90 minutes]
Secondary outcome measures (12)
  • Median Ki in the lumbar spine [Time frame: 90 minutes]
  • Ki in other bones. [Time frame: 90 minutes]
  • Bone perfusion (K1) [Time frame: 90 minutes]
  • Bone incorporation fraction (K3/K3+K2) [Time frame: 90 minutes.]
  • Mean difference in CTX [Time frame: 90 minutes.]
  • Mean difference in P1NP [Time frame: 90 minutes]
  • Mean difference in PTH. [Time frame: 90 minutes.]
  • Mean difference in GIP(1-42) [Time frame: 90 minutes.]
  • Mean difference in GLP-2(1-33) [Time frame: 90 minutes.]
  • Mean difference in pramlintide [Time frame: 90 minutes.]
  • Mean difference in blood glucose [Time frame: 90 minutes.]
  • Mean difference in C-peptide [Time frame: 90 minutes.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Rigshospitalet — Copenhagen

Identifiers

NCT: NCT07679516 · GA-27-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗