The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals
- Conditions
- Effect of iv Administration of GIP and Alanine
- Interventions
- Registration Number
- NCT06419686
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 10
- Caucasian ethnicity
- Body mass index (BMI) 20-27 kg/m^2
- Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
- Informed and written consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GIP + Alanine 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. Saline Placebo (saline) Intravenous administration of saline for 90 minutes. Alanine Alanine Intravenous administration of alanine for 90 minutes (28 umol/kg/min). GIP GIP Intravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes.
- Primary Outcome Measures
Name Time Method Plasma concentrations of Glucagon Timepoint -30 to 90 minutes Baseline-corrected area under the curve (bsAUC)
- Secondary Outcome Measures
Name Time Method Serum concentration of C-peptid Timepoint -30 to 90 minutes Baseline-corrected area under the curve (bsAUC).
Circulating levels of total amino acids Timepoint -30 to 90 minutes Baseline-corrected area under the curve (bsAUC).
Circulating levels of P1NP Timepoint -30 to 90 minutes Baseline-corrected area under the curve (bsAUC).
Pulse Timepoint -30, 0, 30, 60, 90 Baseline-corrected area under the curve (bsAUC).
Plasma concentration of GIP Timepoint -30 to 90 minutes Baseline-corrected area under the curve (bsAUC).
Blood pressure Timepoint -30, 0, 30, 60, 90 Baseline-corrected area under the curve (bsAUC).
Plasma concentration of glucose Timepoint -30 to 90 minutes Peak value
Circulating levels of individual amino acids Timepoint -30 to 90 minutes Baseline-corrected area under the curve (bsAUC).
Serum concentration of Insulin Timepoint -30 to 90 minutes Baseline-corrected area under the curve (bsAUC).
Lipid profile Timepoint -30 to 90 minutes Baseline-corrected area under the curve (bsAUC).
Circulating levels of CTx Timepoint -30 to 90 minutes Baseline-corrected area under the curve (bsAUC).
Trial Locations
- Locations (1)
Center for Clinical Metabolic Research, Gentofte Hospital
🇩🇰Hellerup, Capital Region, Denmark