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

University Hospital, Gentofte, Copenhagen

Status and phase: Enrolling; Phase 1

Conditions: Effect of iv Administration of GIP and Alanine

Treatments: Drug: Alanine; Drug: GIP; Drug: GIP + alanine; Other: Placebo (saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT06419686

H-21066812

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 4 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

Intravenous administration of saline for 90 minutes.

Treatment:

Other: Placebo (saline)

GIP

Experimental group

Description:

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

Treatment:

Drug: GIP

Alanine

Experimental group

Description:

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

Treatment:

Drug: Alanine

GIP + Alanine

Experimental group

Description:

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.

Treatment:

Drug: GIP + alanine