Effect of iv Administration of GIP and Alanine
Conditions
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.
Interventions
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of Glucagon | Timepoint -30 to 90 minutes | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration of C-peptid | Timepoint -30 to 90 minutes | Baseline |
| Plasma concentration of glucose | Timepoint -30 to 90 minutes | Baseline |
| Plasma concentration of GIP | Timepoint -30 to 90 minutes | Baseline |
| Circulating levels of total amino acids | Timepoint -30 to 90 minutes | Baseline |
| Circulating levels of individual amino acids | Timepoint -30 to 90 minutes | Baseline |
| Serum concentration of Insulin | Timepoint -30 to 90 minutes | Baseline |
| Circulating levels of CTx | Timepoint -30 to 90 minutes | Baseline |
| Circulating levels of P1NP | Timepoint -30 to 90 minutes | Baseline |
| Blood pressure | Timepoint -30, 0, 30, 60, 90 | Baseline |
| Pulse | Timepoint -30, 0, 30, 60, 90 | Baseline |
| Lipid profile | Timepoint -30 to 90 minutes | Baseline |
Countries
Denmark
Contacts
Primary ContactJulie V Warnøe, MD
Outcome results
None listed