NCT05391581

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

May 6, 2022

Last Update Submit

December 22, 2023

Conditions

Blood Flow

Keywords

Gut hormonesGIPGLP-2Physiology

Outcome Measures

Primary Outcomes (1)

  • Redistribution of splanchnic blood flow (functional MRI)

    Flow in mesenteric superior artery

    90 minutes

Secondary Outcomes (15)

  • GIP levels

    90 minutes

  • GLP-2 levels

    90 minutes

  • GIP(3-30)NH2 levels

    90 minutes

  • GLP-2(1-33) levels

    90 minutes

  • CTX (bone resorption marker)

    90 minutes

  • +10 more secondary outcomes

Study Arms (8)

SAL-WAT

PLACEBO COMPARATOR

Saline infusion, saline injection, water ingestion

Other: Placebo

SAL-GLU

ACTIVE COMPARATOR

Saline infusion, saline injection, glucose ingestion

Other: Placebo

SAL-GIP

ACTIVE COMPARATOR

Saline infusion, GIP injection, water ingestion

Other: Placebo

SAL-GLP-2

ACTIVE COMPARATOR

Saline infusion, GLP-2 injection, water ingestion

Other: Placebo

GIA-WAT

EXPERIMENTAL

GIPR antagonist infusion, saline injection, water ingestion

Other: GIPR antagonist / study toolOther: Placebo

GIA-GLU

EXPERIMENTAL

GIPR antagonist infusion, saline injection, glucose ingestion

Other: GIPR antagonist / study tool

GLA-WAT

EXPERIMENTAL

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

Other: GLP-2R antagonist / study toolOther: Placebo

GLA-GLU

EXPERIMENTAL

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

Other: GLP-2R antagonist / study tool

Interventions

GIPR antagonist / study toolOTHER

Selective antagonist of the GIPR, GIP(3-30)NH2

GIA-GLUGIA-WAT
GLP-2R antagonist / study toolOTHER

Selective antagonist of the GLP-2R, GLP-2(3-33)

GLA-GLUGLA-WAT
PlaceboOTHER

Saline

GIA-WATGLA-WATSAL-GIPSAL-GLP-2SAL-GLUSAL-WAT

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2200, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Single blind, placebo controlled, randomized, crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 26, 2022

Study Start

January 13, 2022

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Will share upon requests

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE

Locations

DK(1)