NCT06426823

Brief Summary

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.

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 Nov 2023

Typical duration for not_applicable

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

November 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2026

Completed
Last Updated

March 18, 2026

Status Verified

May 1, 2024

Enrollment Period

2.4 years

First QC Date

May 6, 2024

Last Update Submit

March 16, 2026

Conditions

Blood Flow

Keywords

Gut hormonesGIPPhysiologyType 2 diabetes

Outcome Measures

Primary Outcomes (1)

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

    Measued with phase-contrast MRI in ml/min

    80 minutes

Secondary Outcomes (9)

  • GIP levels

    80 minutes

  • GIP(3-30)NH2 levels

    80 minutes

  • Glucose

    80 minutes

  • C-peptide

    80 minutes

  • Insulin

    80 minutes

  • +4 more secondary outcomes

Study Arms (4)

Saline and oral water (SAL-WAT)

PLACEBO COMPARATOR

Saline infusion, oral water ingestion

Other: Saline / placebo

Saline infusion and oral glucose ingestion (SAL-GLU)

ACTIVE COMPARATOR

Saline infusion, oral glucose ingestion

Other: Saline / placebo

GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT)

EXPERIMENTAL

GIPR antagonist infusion, oral water ingestion

Other: GIPR antagonist / study tool

GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU)

EXPERIMENTAL

GIPR antagonist infusion, oral glucose ingestion

Other: GIPR antagonist / study tool

Interventions

Saline / placeboOTHER

NaCl (9 mg/ml)

Saline and oral water (SAL-WAT)Saline infusion and oral glucose ingestion (SAL-GLU)
GIPR antagonist / study toolOTHER

GIP(3-30)NH2

GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU)GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

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, 2024

First Posted

May 23, 2024

Study Start

November 1, 2023

Primary Completion

March 16, 2026

Study Completion

March 16, 2026

Last Updated

March 18, 2026

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Will share upon requests

Locations

DK(1)