Recruiting

GIPALANINThe Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals

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What is being tested

Placebo (saline)

+ GIP

+ Alanine

OtherDrug
Who is being recruted

From 18 to 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorUniversity Hospital, Gentofte, Copenhagen
Study ContactJulie V Warnøe, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2024

Actual date on which the first participant was enrolled.

This study aims to explore how two substances, glucose-dependent insulinotropic polypeptide (GIP) and alanine, influence hormone levels in healthy men. Researchers want to see if these substances, given separately or together, can increase the levels of glucagon, a hormone that raises blood sugar levels, under normal blood sugar conditions. Understanding these effects can help advance knowledge about how gut hormones and amino acids interact, which could potentially lead to better treatments for managing blood sugar levels. Participants in this study receive an intravenous infusion of either a placebo, GIP, alanine, or a combination of GIP and alanine on four different days. Each session lasts 90 minutes, and the order in which they receive these treatments is randomized. The study evaluates how these treatments affect glucagon levels, insulin secretion, and the concentration of various amino acids in the blood. Since the study is double-blinded, neither the participants nor the researchers know which treatment is being administered on a given day, reducing bias and ensuring more reliable results.

Official TitleThe Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals
NCT06419686
Principal SponsorUniversity Hospital, Gentofte, Copenhagen
Study ContactJulie V Warnøe, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Caucasian ethnicity

Body mass index (BMI) 20-27 kg/m^2

Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol

Informed and written consent

6 exclusion criteria prevent from participating
Late microvascular complications except mild nonproliferative retinopathy

Liver disease (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder

Treatment with any glucose-lowering drugs

Active or recent (within 5 years) malignant disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Intravenous administration of saline for 90 minutes.

Group II

Experimental
Intravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes.

Group III

Experimental
Intravenous administration of alanine for 90 minutes (28 umol/kg/min).

Group IV

Experimental
Intravenous administration of GIP and alanine for 90 minutes. GIP is given at a priming dose of 6 pmol/kg/min for 10 minutes and then 4 pmol/kg for 80 minutes. Alanine is given at 28 umol/kg/min for 90 minutes.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, DenmarkOpen Center for Clinical Metabolic Research, Gentofte Hospital in Google Maps
Recruiting
One Study Center