Meal-regulated Substrate Metabolism, Influence of Obesity and IL-6

Sponsor
Rigshospitalet, Denmark
Study ID
NCT04687540
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Tocilizumab — DRUG
    Baseline: Tocilizumab (infusion of 8 mg/kg bodyweight or a maximum of 800 mg) will be infused over 60 minutes at the end for the study day, therefore study visit 1 (study day 1) measurements are baseline.
  • Saline 0.9% — DRUG
    Participants are under influence of tocilizumab since the effect of the drug will last for 4 weeks. Participants will be infused with saline at study visit 2 (study day 21). Placebo to tocilizumab will be saline (NaCl 0.9%) as tocilizumab is a colorless solution and has to be diluted with NaCl 0.9% prior to administration

Study Details

The overall purpose of this explorative yet quantitative study project is to understand how blocking IL-6 signaling leads to the expansion of adipose tissue mass in humans in vivo. The aim is to gain in depth knowledge about how IL-6 receptor blockade affects human lipid, glucose and protein metabolism, specifically the uptake and storage of substrates from a meal vs. their utilization, hence the balance determining whether one gains or loses fat mass.

Key Dates

Start date
Apr 9, 2021
Status verified
Apr 2022
Primary completion
Aug 1, 2021
Completion
Aug 1, 2021

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Study day 1 (study visit 1)
    Baseline measurements (pre-intervention) are obtained on study visit 1.
  • Active Comparator: Study day 21 (study visit 2)
    Post-intervention measurements: Participants will be under the influence of tocilizumab, which was injected at the end of study visit 1.

Primary Outcome Measure

Whole-body, fat and skeletal muscle fat turnover [ Time Frame: 0-21 days ]

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