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Completed

NCT Number: NCT06721910

Interplay Between Interleukin-6 and Glucagon in the Regulation of Human Amino Acid and Protein Homeostasis

The goal of this proof-of-concept study is to learn if interleukin-6 changes the effect of glucagon in healthy volunteers. The main question it aims to answer is:

Does IL-6 influence how effectively glucagon lowers the concentration of amino acids in blood? Researchers will compare the infusion of normal saline and a blocker of the receptor for interleukin-6 to see if blocking interluekin-6 changes how effectively glucagon lowers the concentration of amino acids in blood.

Participants will be asked to

* receive either an infusion of normal saline or the interleukin-6 receptor blocker * participate in a study visit three weeks later at which they will receive infusions of hormones and amino acids to mimic the concentrations of the hormones insulin and glucagon during fasting or fed conditions * labelled glucose, glycerol and amino acids will also be infused continuously to track the fate of these molecules * during the hormone infusions blood samples will be taken repeatedly

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Key information

Conditions

Healthy Amino Acid Change Glucagon Resistance

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18 to 50 years
  • BMI 18.5 - 25 kg/m2
  • Stable body weight in the past 6 months before study initiation
  • Women should be anovulatory on non-cyclic hormone replacement or hormonal contraception

Exclusion criteria

  • Previous medical history for any chronic condition in the last three months, active disease or abnormal physical examination as verified by a qualified physician
  • Body weight unstable in the past 6 months
  • Use of tobacco/nicotine
  • Alcohol consumption >30g/day
  • Participation in an investigational drug trial within the past two months
  • Current intake of any drugs (prescribed, over the counter or recreational)
  • Known allergy to tocilizumab
  • Pregnant or lactating women,
  • Inability or unwillingness to provide informed consent

Treatment and study plan

Tocilizumab

Drug

Blockade of the interleukin-6 receptor

Placebo

Other

Infusion of 100 ml normal saline

Primary outcomes

  1. Change in maximum glucagon-induced reduction in total plasma amino acid concentrations

    Time frame: At visit 2 during high glucagon phase (80-120 minutes)

Secondary outcomes

  1. AUC of total amino acids

    Time frame: At visit 2 during high glucagon phase (80-120 minutes)

  2. rate of phenylalanine oxidation

    Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)

  3. urea concentrations

    Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)

  4. rate of gluconeogenesis from amino acids

    Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)

  5. fractional synthesis rate of plasma proteins

    Time frame: At visit 2 (60, 180, 300 minutes)

  6. Amino acid uptake by PBMCs ex vivo

    Time frame: At visit 1 and visit 2 (-120 minutes)

  7. Change in fractional synthesis rate of lipoproteins

    Time frame: At visit 2 (60, 180, 300 minutes)

  8. Cytokine plasma concentrations (IL-6, IL-1RA, TNF-alpha, IL-8, IL-10, CRP)

    Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)

  9. Plasma concentrations of insulin, c-peptide, glucagon, GH, IGF-1, cortisol, catecholamines, fT4, fT3, FGF21, follistatin, AGPTL4, ketones

    Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)

  10. Energy expenditure kcal/24 hours

    Time frame: At visit 2 (40, 160, 280 minutes)

  11. Respiratory exchange rate

    Time frame: At visit 2 (40, 160, 280 minutes)

  12. Oxygen consumption (VO2 ml/minutes)

    Time frame: At visit 2 (40, 160, 280 minutes)

  13. Carbondioxid production (VCO2 ml/minutes)

    Time frame: At visit 2 (40, 160, 280 minutes)

  14. Body composition (lean body mass kg)

    Time frame: At visit 1 and 2 (-120 minutes)

  15. Body composition (fat bodymass kg)

    Time frame: At visit 1 and 2 (-120 minutes)

  16. Blood pressure systolic

    Time frame: At visit 2 (-120 minutes)

  17. Blood pressure diastolic

    Time frame: At visit 2 (-120 minutes)

  18. Heart rate

    Time frame: At visit 2 (-120minutes)

Other outcomes

  1. Changes in protein profiles

    Time frame: At visit 2 (60, 180, 300 minutes)

    Using untargeted and targeted proteomic platforms, the changes in protein profiles in the plasma will be measured

  2. Changes in metabolite profiles

    Time frame: At visit 2 (60, 180, 300 minutes)

    Using untargeted and targeted metabolomic platforms, the changes in metabolite profiles in the plasma serum will be measured

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: IGLU

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Oct 3, 2025

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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