ClinicalTrials.Veeva

Menu

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

University of Copenhagen logo

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

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

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

Trial contacts and locations

1

Loading...

Central trial contact

Lærke S Gasbjerg, MD, Ph; Mette M Rosenkilde, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems