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

Study acronym: GINEBRA
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Nov 1, 2026 to Sep 17, 2026
    • Enrollment target: estimated 12 to confirmed 13
    • Eligibility criteria expanded, about 6 words
    • Site details revised
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Apr 1, 2026 to Nov 1, 2026
    • Start date changed from estimate of Apr 1, 2025 to Nov 10, 2025
    • Study completion date: Apr 30, 2027 to Nov 30, 2027
    • Site details revised
  3. Minor Eligibility criteria expanded, about 1 wordv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06790225
Lead Sponsor Esbjerg Hospital - University Hospital of Southern Denmark
Conditions
(from sponsor)
Bone Disease, Metabolic, Diabetes Mellitus, Type 2, Obesity and Obesity-related Medical Conditions
Related terms Bone Diseases, Metabolic, Diabetes Mellitus, Type 2, Obesity
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov