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NCT06790225Completed

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
13 (actual)
First submitted
17 Jan 2025
Start date
10 Nov 2025
Primary completion date
17 Sept 2026
Lead sponsor
Esbjerg Hospital - University Hospital of Southern Denmark
NCT number
NCT06790225

What you commit to

  • Study type: Interventional
  • Participants enrolled: 13
  • From 10 Nov 2025 to the primary completion date, 17 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • pre-diabetes or diabetes (HbA1c \>42mmol/mol)

Other

  • BMI \>28
  • fractures with \< 6months
  • comorbidities/treatments that may influence bone metabolism or procedures - -- pregnancy
  • inability to provide informed concent

Who the study is looking for

  • healthy volunteers

Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital of Southern Denmark
Coordinator of this site? Confirm its status
EsbjergDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.