The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Effect of iv Administration of GIP and Alanine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Saline

Intravenous administration of saline for 90 minutes.

Group Type PLACEBO_COMPARATOR

Placebo (saline)

Intervention Type OTHER

Intravenous saline during experimental days.

GIP

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

Group Type EXPERIMENTAL

GIP

Intervention Type DRUG

Intravenous GIP administration during experimental days.

Alanine

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

Group Type EXPERIMENTAL

Alanine

Intervention Type DRUG

Intravenous alanine administration during experimental days.

GIP + Alanine

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.

Group Type EXPERIMENTAL

GIP + alanine

Intervention Type DRUG

Intravenous administration of GIP and alanine during experimental days.

Interventions

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Placebo (saline)

Intravenous saline during experimental days.

Intervention Type OTHER

GIP

Intravenous GIP administration during experimental days.

Intervention Type DRUG

Alanine

Intravenous alanine administration during experimental days.

Intervention Type DRUG

GIP + alanine

Intravenous administration of GIP and alanine during experimental days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes