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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Infusion of 100 ml normal saline |
|
| IL-6R ab | Active Comparator | Infusion of tocilizumab, 8mg/kg body weight or max. 800mg in 100 ml normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Blockade of the interleukin-6 receptor |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximum glucagon-induced reduction in total plasma amino acid concentrations | At visit 2 during high glucagon phase (80-120 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in protein profiles | Using untargeted and targeted proteomic platforms, the changes in protein profiles in the plasma will be measured | At visit 2 (60, 180, 300 minutes) |
| Changes in metabolite profiles |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beckey Trinh, MD, PhD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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Randomized, double-blind, parallel
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Double-blind
| Other |
Infusion of 100 ml normal saline |
|
| 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) |
| Amino acid uptake by PBMCs ex vivo | At visit 1 and visit 2 (-120 minutes) |
| Change in fractional synthesis rate of lipoproteins | At visit 2 (60, 180, 300 minutes) |
| Cytokine plasma concentrations (IL-6, IL-1RA, TNF-alpha, IL-8, IL-10, CRP) | At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes) |
| Plasma concentrations of insulin, c-peptide, glucagon, GH, IGF-1, cortisol, catecholamines, fT4, fT3, FGF21, follistatin, AGPTL4, ketones | At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes) |
| Energy expenditure kcal/24 hours | At visit 2 (40, 160, 280 minutes) |
| Respiratory exchange rate | At visit 2 (40, 160, 280 minutes) |
| Oxygen consumption (VO2 ml/minutes) | At visit 2 (40, 160, 280 minutes) |
| Carbondioxid production (VCO2 ml/minutes) | At visit 2 (40, 160, 280 minutes) |
| Body composition (lean body mass kg) | At visit 1 and 2 (-120 minutes) |
| Body composition (fat bodymass kg) | At visit 1 and 2 (-120 minutes) |
| Blood pressure systolic | At visit 2 (-120 minutes) |
| Blood pressure diastolic | At visit 2 (-120 minutes) |
| Heart rate | At visit 2 (-120minutes) |
Using untargeted and targeted metabolomic platforms, the changes in metabolite profiles in the plasma serum will be measured
| At visit 2 (60, 180, 300 minutes) |