Skip to main content
OpenTrials
Completed

NCT Number: NCT05177653

Separate and Combined Extrapancreatic Effects of the Incretin Hormones

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research

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
  • Blood haemoglobin >7 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-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

Treatment and study plan

Intravenous Infusion

Other

GIP receptor antagonist (GIP(3-30)NH2)

Primary outcomes

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

    Time frame: Up to two months

    mmol/l

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

    Time frame: Up to two months

    pmol/l

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

    Time frame: Up to two months

    pmol/l

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

    Time frame: Up to two months

    mmol/l lipoproteins, neutral and complex lipids.

  5. Changes in plasma lipoproteins between interventions assessed through frequently blood sampling during the experimental days.

    Time frame: Up to two months

    mg/dl

  6. Changes in brown adipose tissue activity between interventions, assessed by thermographic camera

    Time frame: Up to two months

  7. Changes in adiponectin in plasma between interventions, assessed through frequently blood sampling during the experimental days.

    Time frame: Up to two months

    μg/mL

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

    Time frame: Up to two months

    ng/ml

  9. Changes in plasma P1NP between interventions assessed through frequently blood sampling during the experimental days

    Time frame: Up to two months

    ng/ml

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 and Glucagon-like Peptide 1

Acronym: GA-19

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2022
Registry last updated
Mar 29, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.