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

University Hospital Basel

Status: Completed

Conditions: Healthy; Amino Acid Change; Glucagon Resistance

Treatments: Other: Placebo; Drug: Tocilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06721910

IGLU

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Infusion of 100 ml normal saline

Treatment:

Other: Placebo

IL-6R ab

Active Comparator group

Description:

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

Treatment:

Drug: Tocilizumab