NCT06194955

Brief Summary

This project will characterize the physiological effect of the hormones, GIP-, GLP-1- and GLP-2 infusions in a group of individuals that are carriers of GIP-, GLP-1- and GLP-2 receptor gene variants, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

January 4, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

December 22, 2023

Last Update Submit

April 28, 2026

Conditions

Incretin Effect

Keywords

Gut hormonessingle nucleotide variants (SNVs)GIPGLP-1GLP-2

Outcome Measures

Primary Outcomes (2)

  • For GIP- and GLP-1 receptor variants: Insulinotropic effect (C-peptide)

    Blood sample

    240 minutes

  • For GLP-2 receptor variants: CTX (bone resorption marker)

    Blood sample

    120 minutes

Secondary Outcomes (8)

  • GIP levels

    240 minutes

  • GLP-1 levels

    240 minutes

  • GLP-2 levels

    240 minutes

  • CTX (bone resorption marker)

    240 minutes

  • P1NP (bone formation marker)

    240 minutes

  • +3 more secondary outcomes

Study Arms (6)

GIPR variant carriers

ACTIVE COMPARATOR

Inidividuals with GIPR variants: Determination of the incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp.

Drug: GIP(1-42)Drug: GLP-1Other: Placebo

GIPR variant carrier controls

PLACEBO COMPARATOR

Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp.

Drug: GIP(1-42)Drug: GLP-1Other: Placebo

GLP-1R variant carrier

ACTIVE COMPARATOR

Individuals with GLP-1R variants: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp

Drug: GIP(1-42)Drug: GLP-1Other: Placebo

GLP-1R variant carrier controls

PLACEBO COMPARATOR

Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of to GIP and GLP-1 infusions during hyperglycemic clamp.

Drug: GIP(1-42)Drug: GLP-1Other: Placebo

GLP-2R variant carrier

ACTIVE COMPARATOR

Individuals with GLP-2R variants: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels

Drug: GLP-2Other: Placebo

GLP-2R variant carrier control

PLACEBO COMPARATOR

Healthy matched individuals: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels

Drug: GLP-2Other: Placebo

Interventions

GIP(1-42)DRUG

Infusion

GIPR variant carrier controlsGIPR variant carriersGLP-1R variant carrierGLP-1R variant carrier controls
GLP-1DRUG

Infusion

GIPR variant carrier controlsGIPR variant carriersGLP-1R variant carrierGLP-1R variant carrier controls
GLP-2DRUG

Infusion

GLP-2R variant carrierGLP-2R variant carrier control
PlaceboOTHER

Saline

GIPR variant carrier controlsGIPR variant carriersGLP-1R variant carrierGLP-1R variant carrier controlsGLP-2R variant carrierGLP-2R variant carrier control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 19-35 kg/m2

You may not qualify if:

  • Treatment with medication or supplements that can not be discontinued for 12 hours
  • \>10 objects of alcohol weekly or abuse of narcotics
  • Liver disease (defined as ALAT and/or ASAT ≥ 2 x normal levels)
  • Decreased kidney function (creatine levels over reference interval)
  • Uncontrollable increased blood pressure (\> 140/90 mmHg)
  • Low blood percentage (hemoglobin \< 8.3 mmol/l)
  • Special diet or planned weight change during trial period
  • 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)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Interventions

gastric inhibitory polypeptide (1-42)Glucagon-Like Peptide 1

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

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, randomized, crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 8, 2024

Study Start

January 4, 2023

Primary Completion

December 10, 2025

Study Completion

April 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations

DK(1)