Separate and Combined Extrapancreatic Effects of Glucose-dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide 1 (GLP-1)
| Registry | NCT06895408, acronym GA-19b |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, basic science |
| Enrollment | 12 (Actual) |
| Sponsor | University Hospital, Gentofte, Copenhagen (Other) |
| Conditions | Pancreatectomy; Hyperglycemia |
| Interventions | Intravenous Infusion (Other) |
| Dates | start 2025-02-19, primary completion 2025-07-14, completion 2025-07-14, first posted 2025-03-26, last updated 2025-09-09 |
| Locations | 1 site in Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Pancreatectomy; Hyperglycemia All trials of Intravenous Infusion
The two gut-derived hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) are secreted from intestinal cells in relation to a meal and increase insulin secretion from the pancreas. The hormones also exert effects outside the pancreas, but especially for GIP, these are poorly investigated. Because of this, only GLP-1 based drugs (GLP-1 receptor agonists) are on the market for the treatment of type 2 diabetes and obesity. Nonetheless, a new drug is in clinical development: a combined GIP-GLP-1-receptor agonist (tirzepatide), which has shown better results than GLP-1 alone. The mechanism behind these impressive effects are unknown and in this study, the investigators will look into the exptrapancreatic effects of GIP and GLP-1, separate and combined and thus elucidate the mechanisms of action of this new drug class.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| GIP | Experimental | Other: Intravenous Infusion | Intravenous infusion of glucose-dependent insulinotropic polypeptide |
| GLP-1 | Experimental | Other: Intravenous Infusion | Intravenous infusion of glucagon-like peptide 1 |
| GIP + GLP-1 | Experimental | Other: Intravenous Infusion | Intravenous infusion of glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 |
| Saline | Placebo comparator | Other: Intravenous Infusion | Intravenous infusion of saline |
Sex: All, ages: 30 Years to 75 Years
Inclusion Criteria: * Total pancreatectomy * Caucasians between 30-75 years of age * Blood haemoglobin >7.0 mmol/l for males and >6.5 mmol/l for females Exclusion Criteria: * Pancreatectomy within the last 3 months * Ongoing chemotherapy or chemotherapy within the last 3 months * Treatment with GLP-1 receptor agonists within the last 3 months * Renal impairment (estimated by estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2) and/or albuminuria * Calcium related disease, hypo-/hyperthyroidism * Known significant liver disease, plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × normal value or INR (The international normalised ratio based on prothrombin time) outside the normal range * Severe arteriosclerotic heart disease or heart failure (New York Heart Association (NYHA) group III or IV) * Pregnancy and/or breastfeeding * Use of more than 14 units of alcohol per week or abuse of narcotics * Any condition that the investigator feels would interfere with trial participation
| Facility | City | Country | Status |
|---|---|---|---|
| Center for Clinical Metabolic Research, Gentofte Hospital | Hellerup | Denmark |