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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06790225
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-24
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Study Start: 2025-04-01
• Primary Completion: 2026-04-01
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Serum levels of CTX	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)

Secondary Outcome Measures

Name	Time	Method
Serum levels of osteocalcin and P1NP	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)
Serum levels of GIP	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)

Trial Locations

Locations (1)

University hospital of Southern Denmark; 🇩🇰 Esbjerg, Denmark