Glucose-dependent INsulinotropic Polypeptide: Effect on Bone Remodelling and Cell Activity (GINEBRA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glucose-dependent Insulinotropic Polypeptide (GIP).
- Who it may be relevant to
- Registry conditions: Bone Disease, Metabolic, Diabetes Mellitus, Type 2, Obesity and Obesity-related Medical Conditions. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Glucose-dependent Insulinotropic Polypeptide (GIP)
Recombinant human GIP (1-42)
Primary outcome measures
- Serum levels of CTX [Time frame: During a three day period. With 14-28 days of washout between the two administration methods]
Secondary outcome measures (2)
- Serum levels of osteocalcin and P1NP [Time frame: During a three day period. With 14-28 days of washout between the two administration methods]
- Serum levels of GIP [Time frame: During a three day period. With 14-28 days of washout between the two administration methods]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- University hospital of Southern Denmark — Esbjerg
Identifiers
NCT: NCT06790225 · 25/2685