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

NCT ID: NCT06790225

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-10
• Study Completion Date: 2027-11-30

Brief Summary

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.

Conditions

Bone Disease, Metabolic; Diabetes Mellitus, Type 2; Obesity and Obesity-related Medical Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intermittent then continious

The participants that recive the intermittent administration first, followed by the continious

Group Type: EXPERIMENTAL

Glucose-dependent Insulinotropic Polypeptide (GIP)

Intervention Type: OTHER

Recombinant human GIP (1-42)

Continious then intermittent

The participants that recives the continious administration first, follwoed by the intermittent

Group Type: EXPERIMENTAL

Glucose-dependent Insulinotropic Polypeptide (GIP)

Intervention Type: OTHER

Recombinant human GIP (1-42)

Interventions

Glucose-dependent Insulinotropic Polypeptide (GIP)

Recombinant human GIP (1-42)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University hospital of Southern Denmark

Esbjerg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Tobias Midtvedt Windedal, MD

Role: CONTACT

tobias.midtvedt.windedal@rsyd.dk

42957945

Facility Contacts

Tobias Windedal, MD

Role: primary

tobias.midtvedt.windedal@rsyd.dk

42957945

Other Identifiers

25/2685

Identifier Type: -

Identifier Source: org_study_id