Investigating the effects of GIP and GLP-1 hormones on insulin secretion and metabolism
Separate and Combined Extrapancreatic Effects of Glucose-dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide 1 (GLP-1)
This study is testing how two gut hormones, GIP and GLP-1, affect insulin production and metabolism in people who have had their pancreas removed, to see if they can help improve treatments for diabetes and obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Gentofte, Copenhagen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hellerup) |
| Trial ID | NCT06895408 on ClinicalTrials.gov |
What this trial studies
This study examines the separate and combined effects of two gut hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1), on insulin secretion and metabolic processes in patients who have undergone total pancreatectomy. The research aims to understand the extrapancreatic effects of these hormones, particularly focusing on GIP, which has been less studied compared to GLP-1. Participants will receive intravenous infusions of these hormones to evaluate their mechanisms of action, especially in light of a new combined GIP-GLP-1 receptor agonist currently in development. The findings could provide insights into better treatment options for conditions like type 2 diabetes and obesity.
Who should consider this trial
Good fit: Ideal candidates for this study are Caucasian individuals aged 30-75 who have undergone total pancreatectomy and have specific blood hemoglobin levels.
Not a fit: Patients who have had a pancreatectomy within the last 3 months or those with significant comorbidities such as renal impairment or severe heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with type 2 diabetes and obesity by elucidating the mechanisms of action of a new class of drugs.
How similar studies have performed: While GLP-1 receptor agonists have been successful in treating diabetes, the specific combined approach of GIP and GLP-1 is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hellerup
- Center for Clinical Metabolic Research, Gentofte Hospital — Hellerup, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.