Glucose-dependent INsulinotropic Polypeptide: Effect on Bone Remodelling and Cell Activity (GINEBRA) (GINEBRA)

December 29, 2025 updated by: Esbjerg Hospital - University Hospital of Southern Denmark

Glucose-dependent insulinotropic polypeptide (GIP) is released by the intestines in response to food intake and increases insulin secretion. Although short-term (< 3 hours) stimulation with GIP decreases bone resorption in humans, the effect may vanish following continuous administration within 24 hours, at least in patients with type 1 diabetes. Whether the anti-resorptive effect of GIP can be maintained if the hormone is non-continuously administrated is unclear. As the first GIP receptor (GIPR) agonist, tirzepatide was recently approved for the treatment of obesity and type 2 diabetes in the USA and type 2 diabetes alone in the EU, there is a need to establish knowledge about the long-term effects of GIP on bone health, including if different exposure times to GIP have different skeletal effects.

This project will investigate whether GIP maintains its anti-resorptive potential if given as intermittent compared to continuous infusion in healthy men and women aged 18-40 years. Administration cycles involve intermittent (8 hours daily) and continuous (24 hours daily) injection of GIP for three days each. The effect of GIP will be measured by bone markers in blood samples, as well as in vitro activity and genetic alterations of bone cells (osteoclasts and osteoblasts) using bone marrow aspirates and bone marrow biopsies. Each participant will receive both administration cycles using a crossover design with a 14-28 days washout period between administrations of GIP.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • pre-diabetes or diabetes (HbA1c >42mmol/mol)
  • BMI >28
  • fractures with < 6months
  • comorbidities/treatments that may influence bone metabolism or procedures - -- pregnancy
  • inability to provide informed concent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent then continious
The participants that recive the intermittent administration first, followed by the continious
Other: Glucose-dependent Insulinotropic Polypeptide (GIP)
Recombinant human GIP (1-42)
Experimental: Continious then intermittent
The participants that recives the continious administration first, follwoed by the intermittent
Other: Glucose-dependent Insulinotropic Polypeptide (GIP)
Recombinant human GIP (1-42)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum levels of CTX
Time Frame: During a three day period. With 14-28 days of washout between the two administration methods
Serum levels of CTX (bone resorption marker) will be measured prior to, during, and at after the intervention, with both administration methods (continious and intermittent)
During a three day period. With 14-28 days of washout between the two administration methods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum levels of osteocalcin and P1NP
Time Frame: During a three day period. With 14-28 days of washout between the two administration methods
Serum levels of osteocalcin and P1NP (bone formation markers) will be measured prior to, during, and at after the intervention, with both administration methods (continious and intermittent)
During a three day period. With 14-28 days of washout between the two administration methods
Serum levels of GIP
Time Frame: During a three day period. With 14-28 days of washout between the two administration methods
Serum levels of GIP will be measured prior to, during, and at after the intervention, with both administration methods (continious and intermittent)
During a three day period. With 14-28 days of washout between the two administration methods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/2685

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual participant data will not be shared following GDPR and local data mangament regulation. However data(anonymous) and results will be published once the study is completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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