The Glucagonotropic Effect of Amino Acids in Humans

Healthy Clinical Trial

— STAMINA  

Official title:

The Glucagonotropic Effect of Amino Acids in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05954923
• Other study ID #: STAMINA
• Status: Completed
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Amino acid bolus infusion
Equimolar bolus infusions of amino acids or saline (placebo)

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	The Novo Nordisk Foundation Center for Basic Metabolic Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolic clearance of amino acids	The metabolic clearance of each infused amino acid calculated from amino acid concentrations	Time 0 min to time 60 min
Other	Insulin	plasma concentration of insulin during the experiment	Time -15 min to time 60 min
Other	C-peptide	plasma concentration of C-peptide during the experiment	Time -15 min to time 60 min
Other	Total and individual amino acids	plasma concentration of total and individual amino acids during the experiment	Time -15 min to time 60 min
Other	GLP-1	plasma concentration of glucagon-like peptide 1 (GLP-1) during the experiment	Time -15 min to time 60 min
Other	GIP	plasma concentration of glucose-dependent insulinotropic polypeptide (GIP) during the experiment	Time -15 min to time 60 min
Primary	bsAUC30	Baseline subtracted area under the curve for glucagon concentration during the first 30 minutes of the experiment	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
Secondary	AUC30	total area under the curve for glucagon concentration during the first 30 minutes of the experiment	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
Secondary	AUC60	total area under the curve for glucagon concentration the first 60 minutes of the experiment	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
Secondary	bsAUC60	Baseline subtracted area under the curve for glucagon concentration during the first 60 minutes of the experiment	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
Secondary	peak glucagon concentration	the highest concentration of glucagon after infusion of amino acids/placebo	measured between time 0 min and time 60 min