Clinical trial NCT06334653: Exercise-regulated Organ Crosstalk, Influence of IL-6
Official title: Exercise-regulated Organ Crosstalk, Influence of IL-6
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers Only
Energy Metabolism
Keywords: tocilizumab
exercise
IL-6
extracellular vesicles
energy
muscle
liver
brain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Overall the study investigates organ crosstalk during exercise. More specifically, the study investigates the role of IL-6 in regulating glucose, fatty acid, and amino acid kinetics at whole body level and in skeletal muscle, liver, and brain. Furthermore, the study investigates the uptake and release of extracellular vesicles in skeletal muscle, liver, and brain in reponse to exercise.


Eligibility criteria: Inclusion Criteria:

* Minimum age: 18 years
* Maximum age: 45 years
* Minimum BMI: 18
* Maximum BMI: 25
* Sex: Male
* Healthy (based on screening)
* Stable body weight for 6 months
* VO2max (mL/kg/min) ≥ 50

Exclusion Criteria:

* Smoking
* Thyroid disease
* Heart disease
* Inflammatory diseases
* Current infection
* Liver disease (transaminases more than 2x upper normal range)
* Kidney disease (creatinine more than1.5 mg/dl)
* Known immunosuppressive disease
* Corticosteroid use
* Regular NSAID or paracetamol usage
* Aspirin use more than 100 mg/d
* History of carcinoma
* History of tuberculosis
* Anemia (hematocrit less than 33%)
* WBC less than 1 x 10\^3
* Platelets less than 100 x 10\^3
* Bleeding disorders
* Obstructive pulmonary disease
* Femoral hernia
* Vascular prosthesis
* Vascular thrombosis
* Previous nerve damage
* Many previous femoral catheter installations

Primary outcomes:
measure: Whole body substrate kinetics.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Tissue specific utilization and production of substrates.
timeFrame: Comparisons between study arms are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: IL-6 regulation of protein synthesis and degradation.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Number of EVs from muscle, liver, and brain.
timeFrame: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
measure: Size of EVs from muscle, liver, and brain.
timeFrame: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
measure: EVs from muscle, liver, and brain.
timeFrame: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
measure: Influence of exercise on EV number.
timeFrame: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
measure: Influence of exercise on EV size
timeFrame: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
measure: Influence of exercise on EV content.
timeFrame: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
measure: Tissue specific proteomic content of EVs.
timeFrame: Comparisons between placebo and IL-6R ab are done at the end of a 1-hour exercise bout (330 minutes).
Secondary outcomes:
measure: Lactate.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Pyruvate.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Keto acids.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Ketone bodies.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Influence of IL-6 on fatty acid oxidation rates.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Influence of IL-6 on insulin.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Influence of IL-6 on glucagon.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Influence of IL-6 on epinephrine.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Influence of IL-6 on norepinephrine.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: IL-6 levels.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Influence of IL-6 on substrate usage.
timeFrame: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).
measure: Influence of IL-6 on perceived exertion.
timeFrame: Comparisons between placebo and IL-6R ab are done during exercise (time points 285, 300, 315, and 330 minutes).
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Capital Region
Study officials:
affiliation: Rigshospitalet, Denmark
name: Helga Ellingsgaard, PhD
role: PRINCIPAL_INVESTIGATOR
References: