Current partner codePEPTIDESDE
NCT07679516·Not applicable·INTERVENTIONAL

Postprandial Regulation of Bone Perfusion in Healthy Individuals

Status

Not yet recruiting

Phase

Not applicable

Enrollment

15

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Jul 1, 2026

  2. Study start

    Jul 19, 2026

  3. Primary completion

    May 2028

  4. Study completion

    May 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 9, 2026

Outcomes

What the study measures.

Primary outcomes

Median Ki in the Femur

Time frame · 90 minutes

Kinetic modelling

Secondary outcomes

Median Ki in the lumbar spine

Time frame · 90 minutes

Kinetic modelling

Ki in other bones.

Time frame · 90 minutes

Kinetic modelling

Bone perfusion (K1)

Time frame · 90 minutes

Kinetic modelling

Bone incorporation fraction (K3/K3+K2)

Time frame · 90 minutes.

Kinetic modelling

Mean difference in CTX

Time frame · 90 minutes.

Bone turnover marker.

Mean difference in P1NP

Time frame · 90 minutes

Bone turnover marker

Mean difference in PTH.

Time frame · 90 minutes.

Bone turnover marker.

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.

Eligibility

Who can take part.

Minimum age
25 Years
Maximum age
50 Years
Sex
ALL
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)

Study locations

1 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

Rigshospitalet

Copenhagen, Denmark

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

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