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

NCT06721910 | Completed DMC

• 1 other identifier: IGLU
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Glucagon Resistance; Amino Acid Change

Keywords

interleukin-6; gluagon; pancreatic clamp

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (18)

• AUC of total amino acids

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

• rate of phenylalanine oxidation

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

• urea concentrations

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

• rate of gluconeogenesis from amino acids

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

• fractional synthesis rate of plasma proteins

  At visit 2 (60, 180, 300 minutes)

Other Outcomes (2)

• Changes in protein profiles

  At visit 2 (60, 180, 300 minutes)

• Changes in metabolite profiles

  At visit 2 (60, 180, 300 minutes)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Infusion of 100 ml normal saline

Other: Placebo

IL-6R ab

ACTIVE COMPARATOR

Infusion of tocilizumab, 8mg/kg body weight or max. 800mg in 100 ml normal saline

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

Blockade of the interleukin-6 receptor

IL-6R ab

Placebo OTHER

Infusion of 100 ml normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

tocilizumab

Study Officials

• Beckey Trinh, MD, PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, parallel

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: December 6, 2024
• Study Start: January 15, 2025
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)