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

H-21066812

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.

2024-01-01

2024-05-01

2024-07-01

Recruiting

Early phase I

10

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2024-05-17