STAMINA: The Glucagonotropic Effect of Amino Acids in Humans

Sponsor

University Hospital, Gentofte, Copenhagen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05954923

Collaborator

Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Amino acid bolus infusion	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

randomized, double-blinded, single-arm study. Participants act as their own controls.randomized, double-blinded, single-arm study. Participants act as their own controls.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Glucagonotropic Effect of Amino Acids in Humans

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Primary arm 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)	Other: Amino acid bolus infusion Equimolar bolus infusions of amino acids or saline (placebo)

Arm

Intervention/Treatment

Experimental: Primary arm

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)

Other: Amino acid bolus infusion

Equimolar bolus infusions of amino acids or saline (placebo)

Outcome Measures

Primary Outcome Measures

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

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
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
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
peak glucagon concentration [measured between time 0 min and time 60 min]
the highest concentration of glucagon after infusion of amino acids/placebo

Other Outcome Measures

Metabolic clearance of amino acids [Time 0 min to time 60 min]
The metabolic clearance of each infused amino acid calculated from amino acid concentrations
Insulin [Time -15 min to time 60 min]
plasma concentration of insulin during the experiment
C-peptide [Time -15 min to time 60 min]
plasma concentration of C-peptide during the experiment
Total and individual amino acids [Time -15 min to time 60 min]
plasma concentration of total and individual amino acids during the experiment
GLP-1 [Time -15 min to time 60 min]
plasma concentration of glucagon-like peptide 1 (GLP-1) during the experiment
GIP [Time -15 min to time 60 min]
plasma concentration of glucose-dependent insulinotropic polypeptide (GIP) during the experiment

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen
Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Malte Palm Suppli, MD, MD, University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT05954923

Other Study ID Numbers:

STAMINA

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 20, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 20, 2023