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Completed

NCT Number: NCT06334653

Exercise-regulated Organ Crosstalk, Influence of IL-6

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.

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Key information

Conditions

Healthy Volunteers Only Behavior Energy Metabolism Motor Activity

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

acute exercise bout

Primary outcomes

  1. Whole body substrate kinetics.

    Time frame: 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).

    Comparing rates of appearances (Ra) and disappearances (Rd) of glucose, glycerol, palmitate, amino acids between placebo and IL-6R ab at rest, during exercise, and recovery.

  2. Tissue specific utilization and production of substrates.

    Time frame: 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).

    Comparing, between placebo and IL-6Rab, by measuring in plasma, the Ra and Rd of substrates in muscle, liver, and brain at rest, during exercise, and recovery using the non-steady-state equations of Steele adapted for stable isotopes.

  3. IL-6 regulation of protein synthesis and degradation.

    Time frame: 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).

    Comparing differences in protein synthesis and degradation rates between placebo and IL-6Rab at rest, during exercise, and during recovery from exercise.

  4. Number of EVs from muscle, liver, and brain.

    Time frame: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).

    Comparing the number of EVs deriving from skeletal muscle, liver, and brain.

  5. Size of EVs from muscle, liver, and brain.

    Time frame: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).

    Comparing EV size deriving from skeletal muscle, liver, and brain.

  6. EVs from muscle, liver, and brain.

    Time frame: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).

    Comparing the content of EVs deriving from skeletal muscle, liver, and brain.

  7. Influence of exercise on EV number.

    Time frame: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).

    Comparing the number of EVs deriving from skeletal muscle, liver, and brain in response to exercise.

  8. Influence of exercise on EV size

    Time frame: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).

    Comparing EV size deriving from skeletal muscle, liver, and brain in response to exercise.

  9. Influence of exercise on EV content.

    Time frame: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).

    Comparing the content of EVs deriving from skeletal muscle, liver, and brain in response to exercise.

  10. Tissue specific proteomic content of EVs.

    Time frame: Comparisons between placebo and IL-6R ab are done at the end of a 1-hour exercise bout (330 minutes).

    Comparing differences in proteomic content of EVs from skeletal muscle, liver, and brain in response to exercise.

Secondary outcomes

  1. Lactate.

    Time frame: 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).

    Differences in plasma lactate from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.

  2. Pyruvate.

    Time frame: 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).

    Differences in plasma pyruvate from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.

  3. Keto acids.

    Time frame: 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).

    Differences in plasma keto acids from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.

  4. Ketone bodies.

    Time frame: 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).

    Differences in plasma ketone bodies from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.

  5. Influence of IL-6 on fatty acid oxidation rates.

    Time frame: 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).

    Comparing, between placebo and IL-6R ab, differences in fatty acid, e.g. palmitate oxidation rates, at whole body level and in skeletal muscle, liver, and brain.

  6. Influence of IL-6 on insulin.

    Time frame: 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).

    Comparing differences in plasma insulin concentrations between placebo and IL-6R ab.

  7. Influence of IL-6 on glucagon.

    Time frame: 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).

    Comparing differences plasma glucagon concentrations between placebo and IL-6R ab.

  8. Influence of IL-6 on epinephrine.

    Time frame: 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).

    Comparing differences in plasma epinephrine concentrations between placebo and IL-6R ab.

  9. Influence of IL-6 on norepinephrine.

    Time frame: 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).

    Comparing differences in plasma norepinephrine concentrations between placebo and IL-6R ab.

  10. IL-6 levels.

    Time frame: 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).

    Comparing differences in plasma IL-6 concentrations between placebo and IL-6R ab.

  11. Influence of IL-6 on substrate usage.

    Time frame: 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).

    Differences in respiratory exchange ratio comparing placebo and IL-6R ab.

  12. Influence of IL-6 on perceived exertion.

    Time frame: Comparisons between placebo and IL-6R ab are done during exercise (time points 285, 300, 315, and 330 minutes).

    Differences in rate of perceived exertion during exercise comparing placebo and IL-6R ab.

Sponsors and collaborators

Lead sponsor

Helga Ellingsgaard

Other

Registry information

Acronym: EVEX

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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