Glucose-dependent insulinotropic polypeptide effects on bone remodeling
Glucose-dependent INsulinotropic Polypeptide: Effect on Bone Remodelling and Cell Activity (GINEBRA)
NA · Esbjerg Hospital - University Hospital of Southern Denmark · NCT06790225
This test will see if giving GIP intermittently versus continuously keeps its bone-protecting, anti-resorptive effect in healthy adults aged 18-40.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark (other) |
| Locations | 1 site (Esbjerg) |
| Trial ID | NCT06790225 on ClinicalTrials.gov |
What this trial studies
This interventional project compares intermittent and continuous administration of glucose-dependent insulinotropic polypeptide (GIP) in healthy men and women aged 18-40 to observe effects on bone remodeling. Participants will receive controlled GIP exposure patterns and have blood markers of bone resorption and formation (such as CTX and P1NP) and measures of bone cell activity monitored over the dosing period. The protocol excludes people with diabetes, BMI over 28, recent fractures, pregnancy, or treatments that affect bone metabolism. Results aim to clarify whether non-continuous dosing preserves GIP's short-term anti-resorptive effects and inform long-term implications for GIP-based therapies.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 18-40 without diabetes or prediabetes, with BMI ≤28, no recent fractures, not pregnant, and not taking medications that affect bone metabolism.
Not a fit: People with diabetes, BMI >28, older adults, active bone disease, or those on bone-active treatments are unlikely to gain direct benefit from participating.
Why it matters
Potential benefit: If successful, the results could guide safer dosing patterns for GIP-based drugs to help protect bone health during obesity or diabetes treatment.
How similar studies have performed: Short-term human studies show GIP can lower bone resorption for a few hours, but continuous exposure has been reported to lose that effect in some patients, so this work builds on limited prior findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Esbjerg
- University hospital of Southern Denmark — Esbjerg, Denmark (RECRUITING)
Study contacts
- Study coordinator: Tobias Midtvedt Windedal, MD
- Email: tobias.midtvedt.windedal@rsyd.dk
- Phone: 42957945
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone Disease, Metabolic, Diabetes Mellitus, Type 2, Obesity and Obesity-related Medical Conditions, GIP, CTX, P1NP, Glucose-dependent insulinotropic polypeptide, Bone remodelling