The Glucagonotropic Effect of Amino Acids in Humans

NCT05954923 | Completed DMC

• 1 other identifier: STAMINA
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• peak glucagon concentration

  measured between time 0 min and time 60 min

Other Outcomes (6)

• Metabolic clearance of amino acids

  Time 0 min to time 60 min

• Insulin

  Time -15 min to time 60 min

• C-peptide

  Time -15 min to time 60 min

Study Arms (1)

Primary arm

EXPERIMENTAL

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

Interventions

Amino acid bolus infusion OTHER

Equimolar bolus infusions of amino acids or saline (placebo)

Primary arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• The Novo Nordisk Foundation Center for Basic Metabolic Research: collaborator

Study Sites (1)

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

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

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: September 5, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)