Clinical trial NCT06419686: The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals
Official title: The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Effect of iv Administration of GIP and Alanine
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a randomised, double-blinded, placebo-controlled, crossover study enrolling 10 healthy male participants. Each participant will undergo four separate study days in randomised order. Each study day encompasses a continous 90-minute i.v. infusion with either placebo, glucose-dependent insulinotropic polypeptide (GIP), alanine or GIP + alanine.

The primary objective of the study is to find out whether intravenous administration of the naturally occuring gut hormone GIP and the amino acid alanine, separately and combined, results in additive or synergistic glucagonotropic effects during euglycaemic conditions in healthy participants. Secondary objectives are to disclose the effect of the abovementioned interventions on insulin secretion and circulating levels of total and individual amino acids.


Eligibility criteria: Inclusion Criteria:

* Caucasian ethnicity
* Body mass index (BMI) 20-27 kg/m\^2
* Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
* Informed and written consent

Exclusion Criteria:

* 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
* Active tobacco smoking/use
* Any condition considered incompatible with participation by the investigators.

Primary outcomes:
measure: Plasma concentrations of Glucagon
timeFrame: Timepoint -30 to 90 minutes
measure: Plasma concentrations of Glucagon
timeFrame: Timepoint -30 to 90 minutes
Secondary outcomes:
measure: Serum concentration of Insulin
timeFrame: Timepoint -30 to 90 minutes
measure: Serum concentration of Insulin
timeFrame: Timepoint -30 to 90 minutes
measure: Serum concentration of C-peptid
timeFrame: Timepoint -30 to 90 minutes
measure: Serum concentration of C-peptid
timeFrame: Timepoint -30 to 90 minutes
measure: Plasma concentration of glucose
timeFrame: Timepoint -30 to 90 minutes
measure: Plasma concentration of glucose
timeFrame: Timepoint -30 to 90 minutes
measure: Plasma concentration of glucose
timeFrame: Timepoint -30 to 90 minutes
measure: Plasma concentration of GIP
timeFrame: Timepoint -30 to 90 minutes
measure: Plasma concentration of GIP
timeFrame: Timepoint -30 to 90 minutes
measure: Circulating levels of total amino acids
timeFrame: Timepoint -30 to 90 minutes
measure: Circulating levels of total amino acids
timeFrame: Timepoint -30 to 90 minutes
measure: Circulating levels of individual amino acids
timeFrame: Timepoint -30 to 90 minutes
measure: Circulating levels of individual amino acids
timeFrame: Timepoint -30 to 90 minutes
measure: Lipid profile
timeFrame: Timepoint -30 to 90 minutes
measure: Lipid profile
timeFrame: Timepoint -30 to 90 minutes
measure: Circulating levels of CTx
timeFrame: Timepoint -30 to 90 minutes
measure: Circulating levels of CTx
timeFrame: Timepoint -30 to 90 minutes
measure: Circulating levels of P1NP
timeFrame: Timepoint -30 to 90 minutes
measure: Circulating levels of P1NP
timeFrame: Timepoint -30 to 90 minutes
measure: Blood pressure
timeFrame: Timepoint -30, 0, 30, 60, 90
measure: Blood pressure
timeFrame: Timepoint -30, 0, 30, 60, 90
measure: Pulse
timeFrame: Timepoint -30, 0, 30, 60, 90
measure: Pulse
timeFrame: Timepoint -30, 0, 30, 60, 90
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolic Research, Gentofte Hospital
state: Capital Region
Study officials:
affiliation: Center for Clinical Metabolic Research, Gentofte Hospital
name: Filip K Knop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: