The Role of GIP and GLP-2 in Postprandial Splanchnic Blood Flow Distribution and Metabolism (GA-17)

University of Copenhagen

Status: Completed

Conditions: Blood Flow

Treatments: Other: GIPR antagonist / study tool; Other: Placebo; Other: GLP-2R antagonist / study tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05391581

GA-17

Details and patient eligibility

About

This project will describe the mechanisms of action and the relative contributions of GIP and GLP-2 to changes in gastrointestinal blood flow induced by oral glucose, exogenous GIP and GLP-2 infusions, and endogenous GIP and GLP-2 with the use of two novel receptor antagonists GIP(3-30)NH2 and GLP-2(3-33) in healthy individuals.

Full description

Each participant will attend eight independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo), subcutaneous injection (hormon/placebo) and oral ingestion (glucose/water). On experimental day A-C, an intravenous infusion of saline, GIP(3-30)NH2, or GLP-2(3-33), respectively, starts at time point -20 minutes. On experimental day D-F, the same 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 experimental days G-H, a subcutaneous injection of either GIP or GLP-2 at time point 0 minutes is performed (positive control) during saline infusion and oral water ingestion.

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

Enrollment: 10 patients

Sex: Male

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No first degree relatives with diabetes
• BMI 20-27 kg/m2

Exclusion criteria

• Not MRI-compatible implants
• Claustrophobia
• Diabetes
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 8 patient groups, including a placebo group

SAL-WAT

Placebo Comparator group

Description:

Saline infusion, saline injection, water ingestion

Treatment:

Other: Placebo

SAL-GLU

Active Comparator group

Description:

Saline infusion, saline injection, glucose ingestion

Treatment:

Other: Placebo

SAL-GIP

Active Comparator group

Description:

Saline infusion, GIP injection, water ingestion

Treatment:

Other: Placebo

SAL-GLP-2

Active Comparator group

Description:

Saline infusion, GLP-2 injection, water ingestion

Treatment:

Other: Placebo

GIA-WAT

Experimental group

Description:

GIPR antagonist infusion, saline injection, water ingestion

Treatment:

Other: Placebo

Other: GIPR antagonist / study tool

GIA-GLU

Experimental group

Description:

GIPR antagonist infusion, saline injection, glucose ingestion

Treatment:

Other: GIPR antagonist / study tool

GLA-WAT

Experimental group

Description:

GLP-2R antagonist infusion, saline injection, water ingestion

Treatment:

Other: Placebo

Other: GLP-2R antagonist / study tool

GLA-GLU

Experimental group

Description:

GLP-2R antagonist infusion, saline injection, glucose ingestion

Treatment:

Other: GLP-2R antagonist / study tool