The Glucagonotropic Effect of Amino Acids in Humans

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Amino acid bolus infusion

• Registration Number: NCT05954923
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

The objective of the study is to delineate the glucagonotropic signal exerted by selected amino acids in human subjects as well as the metabolic clearance rate of these amino acids after intravenous infusion

Detailed Description

After being informed about the study and the potential risks, each participant giving written informed consent will participate in six experimental days. The glucagonotropic effect and metabolic clearance of selected amino acids and saline (placebo), respectively, will be evaluated in 12 healthy individuals. After screening, each participant will undergo 6 double-blinded experimental days performed in randomized order. The experimental days will each last 75 minutes. The amino acids selected for the experiment are glutamine, arginine, alanine, leucine and proline.

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Study Start: 2023-09-05
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• normal fasting plasma glucose and glycated hemoglobin (HbA1c) < 42 mmol/mol
• body mass index (BMI) between 18.5 and 25 kg/m2
• Hemoglobin > 8.3 mmol/L
• Age between 20 and 65 years
• oral and written informed consent

Exclusion Criteria

• Diabetes
• first-degree relatives with diabetes
• fasting plasma triglycerides indicating dyslipidemia (> 2 mmol/L)
• nephropathy (eGFR < 60 ml/min) and/or microalbuminuria (albumine/creatinine ratio > 30 microgram/mg)
• liver disease and/or ALT and/or AST levels > 2 x upper normal reference limits.
• signs of liver fibrosis and/or steatosis evaluated by transient elastography (CAP > 238 dB/min) and/or kPa > 6.0) and/or FIB-4 index > 1.45
• regular use of prescription medication
• use of dietary protein supplementation
• any condition the investigator feels would interfere with trial completion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary arm	Amino acid bolus infusion	This is a single-arm study. Each subject will participate in 6 experimental days in a randomized order. The interventions are equimolar bolus infusions of A) glutamine, B) arginine, C) alanine, D) leucine, E) proline and F) saline (placebo)

Primary Outcome Measures

Name	Time	Method
bsAUC30	bsAUC is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min and 30 min	Baseline subtracted area under the curve for glucagon concentration during the first 30 minutes of the experiment

Secondary Outcome Measures

Name	Time	Method
bsAUC60	bsAUC60 is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min, 30 min and 60 min	Baseline subtracted area under the curve for glucagon concentration during the first 60 minutes of the experiment
AUC30	AUC30 is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min and 30 min	total area under the curve for glucagon concentration during the first 30 minutes of the experiment
peak glucagon concentration	measured between time 0 min and time 60 min	the highest concentration of glucagon after infusion of amino acids/placebo
AUC60	AUC60 is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min, 30 min and 60 min	total area under the curve for glucagon concentration the first 60 minutes of the experiment

Trial Locations

Locations (1)

Center for Clinical Metabolic Research; 🇩🇰 Hellerup, Denmark