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Completed

NCT Number: NCT06426823

The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes

This project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with type 2 diabetes.

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Key information

Conditions

Blood Flow Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2200, Denmark

About this study

Each participant will attend four independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose/water): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes on two of the experimental days (with and without GIP(3-30)NH2).

MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines, pancreas, and bones.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • BMI 20-35 kg/m^2
  • Age 20-80

Exclusion criteria

  • Not MRI-compatible implants
  • Claustrophobia
  • Abnormal kidney or liver function
  • Anemia
  • Planned weight loss or change in diet
  • Hypertension
  • Other conditions that could be expected to affect the primary or secondary outcomes

Treatment and study plan

Saline / placebo

Other

NaCl (9 mg/ml)

GIPR antagonist / study tool

Other

GIP(3-30)NH2

Primary outcomes

  1. Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (functional MRI)

    Time frame: 80 minutes

    Measued with phase-contrast MRI in ml/min

Secondary outcomes

  1. GIP levels

    Time frame: 80 minutes

    Radioimmuno assay on plasma blood sample (pmol/L)

  2. GIP(3-30)NH2 levels

    Time frame: 80 minutes

    Radioimmuno assay on plasma blood sample (nmol/L)

  3. Glucose

    Time frame: 80 minutes

    Bedside measurement of whole blood sample (mmol/L)

  4. C-peptide

    Time frame: 80 minutes

    Electrochemiluminescence immunoassay of plasma blood sample (pmol/L)

  5. Insulin

    Time frame: 80 minutes

    Electrochemiluminescence immunoassay of plasma blood sample (pmol/L)

  6. Glucagon

    Time frame: 80 minutes

    Radioimmuno assay on plasma blood samples (pmol/L)

  7. Blood flow in portal vein

    Time frame: 80 minutes

    Measued with phase-contrast MRI in ml/min

  8. Blood flow in coeliac trunc

    Time frame: 80 minutes

    Measued with phase-contrast MRI in ml/min

  9. Blood flow in hepatic artery

    Time frame: 80 minutes

    Measued with phase-contrast MRI in ml/min

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Acronym: GA-17b

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 23, 2024
Registry last updated
Mar 18, 2026

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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