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Completed

NCT Number: NCT05954923

The Glucagonotropic Effect of Amino Acids in Humans

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

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amino acid bolus infusion

Other

Equimolar bolus infusions of amino acids or saline (placebo)

Primary outcomes

  1. bsAUC30

    Time frame: 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 outcomes

  1. AUC30

    Time frame: 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

  2. AUC60

    Time frame: 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

  3. bsAUC60

    Time frame: 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

  4. peak glucagon concentration

    Time frame: measured between time 0 min and time 60 min

    the highest concentration of glucagon after infusion of amino acids/placebo

Other outcomes

  1. Metabolic clearance of amino acids

    Time frame: Time 0 min to time 60 min

    The metabolic clearance of each infused amino acid calculated from amino acid concentrations

  2. Insulin

    Time frame: Time -15 min to time 60 min

    plasma concentration of insulin during the experiment

  3. C-peptide

    Time frame: Time -15 min to time 60 min

    plasma concentration of C-peptide during the experiment

  4. Total and individual amino acids

    Time frame: Time -15 min to time 60 min

    plasma concentration of total and individual amino acids during the experiment

  5. GLP-1

    Time frame: Time -15 min to time 60 min

    plasma concentration of glucagon-like peptide 1 (GLP-1) during the experiment

  6. GIP

    Time frame: Time -15 min to time 60 min

    plasma concentration of glucose-dependent insulinotropic polypeptide (GIP) during the experiment

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • The Novo Nordisk Foundation Center for Basic Metabolic Research

Registry information

Acronym: STAMINA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2023
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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