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Completed

NCT Number: NCT06895408

Separate and Combined Extrapancreatic Effects of GIP and GLP-1

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.

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Key information

Conditions

Pancreatectomy; Hyperglycemia Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Infusion

Other

Glucose-dependent Insulinotropic Polypeptide

Primary outcomes

  1. Plasma glucose

    Time frame: Up to two months

    Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days

  2. Plasma glucagon

    Time frame: Up to two months

    Changes in plasma levels of glucagon (gut-derived) between interventions assessed through frequently blood sampling during the experimental days

  3. Plasma Insulin/C-peptide

    Time frame: Up to two months

    Changes in plasma levels of insulin/C-peptide between interventions assessed through frequently blood sampling during the experimental days

  4. Plasma triglycerides

    Time frame: Up to two months

    Changes in plasma triglycerides between interventions assessed through frequently blood sampling during the experimental days

  5. Plasma CTX

    Time frame: Up to two months

    Changes in CTX between interventions assessed through frequently blood sampling during the experimental days

  6. Plasma PINP

    Time frame: Up to two months

    Changes in plasma PINP between interventions assessed through frequently blood sampling during the experimental days

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Separate and Combined Extrapancreatic Effects of Glucose-dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide 1 (GLP-1)

Acronym: GA-19b

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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