Postprandial Regulation of Bone Perfusion in Healthy Indi... | NCT07679516

Studies
Postprandial Regulation of Bone Perfusion in Healthy Individuals

NCT07679516

Sponsor

University of Copenhagen

Status

Not yet recruiting

Last Update Posted

Jul 9, 2026Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Healthy Adult Participants
Bone Physiology
Bone Blood Flow Regulation
Peptide Hormones

Interventions

isotonic saline infusion
Infusion of GIP(1-42)
Infusion of GLP-2(1-33)
Infusion of pramlintide

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2026Estimated

Primary Completion Date

May 2028Estimated

Completion Date

May 2028Estimated

First Submitted Date

Jun 25, 2026

First Submission Date that Met QC Criteria

Jun 25, 2026

First Posted Date

Jul 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2026

Last Update Posted Date

Jul 9, 2026Actual

Name	Class
Rigshospitalet, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Isotonic saline	Placebo Comparator	Saltwater infusion in a peripheral vein	Other: isotonic saline infusion
GIP(1-42)	Active Comparator	Infusion of the native hormone GIP(1-42) in a peripheral vein	Other: Infusion of GIP(1-42)
GLP-2(1-33)	Active Comparator	Infusion of the native hormone GLP-2(1-33) in a peripheral vein	Other: Infusion of GLP-2(1-33)
Pramlintide	Active Comparator	Infusion of pramlintide (amylin analogue) in a peripheral vein	Other: Infusion of pramlintide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
isotonic saline infusion	Other	Placebo infusion for comparison of active hormone	Isotonic saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Median Ki in the Femur	Kinetic modelling	90 minutes

Secondary Outcomes

Measure	Description	Time Frame
Median Ki in the lumbar spine	Kinetic modelling	90 minutes
Ki in other bones.	Kinetic modelling	90 minutes

Other Outcomes

Measure	Description	Time Frame
Mean and max SUV (standardized uptake values)		90 minutes.

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Lærke S Gasbjerg, MD, PhD	Contact	+4525346894		lsg@sund.ku.dk
Mette G Thomsen, Cand.Scient	Contact	+4560624598		mette.grodal@sund.ku.dk

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Will share upon request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided