Separate and Combined Extrapancreatic Effects of the Incretin Hormones
- Conditions
- Pancreatectomy; Hyperglycemia
- Interventions
- Other: Intravenous infusion
- Registration Number
- NCT05177653
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- Brief Summary
The two gut-derived hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) is 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- Total pancreatectomy
- Caucasians
- Blood haemoglobin >7 mmol/l for males and >6.5 mmol/l for females
- Pancreatectomy within the last 3 months
- Ongoing chemotherapy or chemotherapy within the last 3 months
- Treatment with GLP-1R agonists within the last 3 months
- Renal impairment (estimated by eGFR <60 ml/min/1.73 m2) and/or albuminuria
- Calcium related disease, hypo-/hyperthyroidism
- Known significant liver disease, ALT or AST >3 times normal value or INR outside normal range
- Severe arteriosclerotic heart disease or heart failure (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GLP-1RA Intravenous infusion - GIPRA + GLP-1RA Intravenous infusion - Saline Intravenous infusion - GIPRA Intravenous infusion -
- Primary Outcome Measures
Name Time Method Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days Up to two months mmol/l
Changes in CTX between interventions assessed through frequently blood sampling during the experimental days Up to two months ng/ml
Changes in plasma levels of insulin/C-peptide between interventions assessed through frequently blood sampling during the experimental days Up to two months pmol/l
Changes in plasma triglycerides between interventions assessed through frequently blood sampling during the experimental days. Up to two months mmol/l lipoproteins, neutral and complex lipids.
Changes in adiponectin in plasma between interventions, assessed through frequently blood sampling during the experimental days. Up to two months μg/mL
Changes in plasma lipoproteins between interventions assessed through frequently blood sampling during the experimental days. Up to two months mg/dl
Changes in plasma levels of glucagon (gut-derived) between interventions assessed through frequently blood sampling during the experimental days Up to two months pmol/l
Changes in plasma P1NP between interventions assessed through frequently blood sampling during the experimental days Up to two months ng/ml
Changes in brown adipose tissue activity between interventions, assessed by thermographic camera Up to two months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center for Clinical Metabolic Research
🇩🇰Hellerup, Denmark