Separate and Combined Extrapancreatic Effects of GIP and GLP-1

Not Applicable

Recruiting

• Conditions: Pancreatectomy; Hyperglycemia

• Registration Number: NCT06895408
• 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) 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-19
• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Plasma glucose	Up to two months	Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days
Plasma glucagon	Up to two months	Changes in plasma levels of glucagon (gut-derived) between interventions assessed through frequently blood sampling during the experimental days
Plasma Insulin/C-peptide	Up to two months	Changes in plasma levels of insulin/C-peptide between interventions assessed through frequently blood sampling during the experimental days
Plasma triglycerides	Up to two months	Changes in plasma triglycerides between interventions assessed through frequently blood sampling during the experimental days
Plasma CTX	Up to two months	Changes in CTX between interventions assessed through frequently blood sampling during the experimental days
Plasma PINP	Up to two months	Changes in plasma PINP between interventions assessed through frequently blood sampling during the experimental days

Trial Locations

Locations (1)

Center for Clinical Metabolic Research, Gentofte Hospital; 🇩🇰 Hellerup, Denmark