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Completed

NCT Number: NCT05349149

IL-6 Regulation of Energy Stores During Recovery From an Acute Exercise Bout

The aim of the study is to investigate the role of exercise-induced IL-6 in regulating energy stores and energy metabolism during recovery after an acute exercise bout. To achieve this, 30 men will be randomized to infusion placebo or tocilizumab (IL-6 receptor antibody) combined with a 2-hour exercise bout. Stable isotope tracers will be infused to determine substrate kinetics. Indirect calorimetry will be applied to determine substrate oxidation, and muscle biopsies will be taken to determine substrate uptake and storage.

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Key information

Conditions

Glycogen Depletion

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Physical Activity Research, Rigshospitalet Section 7641

Copenhagen, Capital Region, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Physically active (defined as meeting the ACSM's guidelines of 2.5h per week of moderate to vigorous physical activity per week), young, healthy males will be included. Participants may be included in the study if they meet all the following criteria:
  • Age ≥ 18 years and ≤ 40 years
  • BMI < 18 and > 25 kg/m2
  • Healthy (based on screening)
  • Stable body weight for 6 months
  • ≥ 2.5h/week moderate to vigorous physical activity

Exclusion criteria

  • • Cardiovascular disease
  • Rheumatologic disease
  • Metabolic disease
  • Elite sports or high aerobic training status (VO2max > 60 mL O2/min/kg)
  • Frequent/chronic use of medications affecting physical performance or inflammation (NSAIDS, DMARDS, corticosteroids)
  • Aspirin use >100 mg/d
  • Thyroid disease
  • Current infection
  • Aspartate amino transferase (AST) or alanine amino transferase (ALT) >2x upper normal range
  • History of carcinoma
  • History of tuberculosis
  • Ketogenic diet
  • Smoking
  • Anemia (hematocrit <33%)
  • Neutrophil count <0,5x 109/l
  • Thrombocytes <50x 109/l or bleeding disorders

Treatment and study plan

Tocilizumab/Actemra® (Roche)

Drug

The infusion of tocilizumab will antagonize IL-6 signaling for the duration of the study, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise

Saline 9%

Drug

The infusion of saline will serve as placebo for tocilizumab, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise

Primary outcomes

  1. Change in muscle glycogen content (mmol/kg/h)

    Time frame: Measured at 0, 120, 180 and 360 minutes

    Comparing change in muscle glycogen in the two groups from before exercise to immediately after exercise, and after 1 hour and 4 hours of recovery

  2. Change in muscle triglycerides content

    Time frame: Measured at 0, 120, 180 and 360 minutes

    Comparing change in muscle triglycerides in the two groups from before exercise to immediately after exercise, and after 1 hour and 4 hours of recovery

  3. Change in muscle expression of glucose transporter type 4 (GLUT4)

    Time frame: Measured at 0, 120 and 360 min

    Comparing muscle expression of GLUT4 before and immediately after exercise and 4 hours after recovery in the two groups

  4. Change in muscle expression of fatty acid translocase (FAT/CD36)

    Time frame: Measured at 0, 120 and 360 min

    Comparing muscle expression of FAT/CD36 before and immediately after exercise and 4 hours after recovery in the two groups

  5. Change in muscle expression of muscle fatty acid binding protein (FABPm)

    Time frame: Measured at 0, 120 and 360 min

    Comparing muscle expression of FABPm before and immediately after exercise and 4 hours after recovery in the two groups

  6. Change in muscle expression of fatty acid transporter 4 (FATP4)

    Time frame: Measured at 0, 120 and 360 min

    Comparing muscle expression of FATP4 before and immediately after exercise and 4 hours after recovery in the two groups

  7. Change in muscle expression of glycerol transporters

    Time frame: Measured at 0, 120 and 360 min

    Comparing muscle expression of glycerol transporters before and immediately after exercise and 4 hours after recovery in the two groups

Secondary outcomes

  1. Change in glucose rate of appearance

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing glucose rate of appearance during exercise and recovery in the two groups

  2. Change in glucose rate of disappearance

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing glucose rate of disappearance during exercise and recovery in the two groups

  3. Change in glucose concentration

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing glucose concentration during exercise and recovery in the two groups

  4. Change in glucose enrichment in intramuscular glycogen

    Time frame: Measured at 0, 120, 180 and 360 minutes

    Comparing glucose enrichment in intramuscular glycogen during rest, exercise and recovery in the two groups

  5. Change in intramuscular glucose concentration

    Time frame: Measured at 0, 120, 180 and 360 minutes

    Comparing intramuscular glucose concentration during rest, exercise and recovery in the two groups

  6. Change in glycogen fractional synthesis rate

    Time frame: Measured at 0, 120, 180 and 360 minutes

    Comparing intramuscular glycogen fractional synthesis rate during rest, exercise and recovery in the two groups

  7. Change in gylcerol rate of appearance

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing gylcerol rate of appearance during rest, exercise and recovery in the two groups

  8. Change in gylcerol rate of disappearance

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing gylcerol rate of disappearance during rest, exercise and recovery in the two groups

  9. Change in gylcerol concentration

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing gylcerol concentration during rest, exercise and recovery in the two groups

  10. Change in palmitate rate of appearance

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing palmitate rate of appearance during rest, exercise and recovery in the two groups

  11. Change in palmitate rate of disappearance

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing palmitate rate of disappearance during rest, exercise and recovery in the two groups

  12. Change in palmitate concentration

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing palmitate kinetics during rest, exercise and recovery in the two groups

  13. Change in palmitate oxidation

    Time frame: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing palmitate oxidation during rest, exercise and recovery in the two groups

  14. Change in intramuscular palmitate content

    Time frame: Measured at 0, 120, 180 and 360 minutes

    Comparing intramuscular palmitate content during rest, exercise and recovery in the two groups

  15. Change in palmitate enrichment in intramuscular triglycerides

    Time frame: Measured at 0, 120, 180 and 360 minutes

    Comparing palmitate enrichment in intramuscular triglycerides during rest, exercise and recovery in the two groups

  16. Change in intramuscular triglycerides fractional synthesis rate

    Time frame: Measured at 0, 120, 180 and 360 minutes

    Comparing intramuscular triglycerides fractional synthesis rate during rest, exercise and recovery in the two groups

  17. Change in haemoglobin

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing haemoglobin during rest, exercise and recovery in the two groups

  18. Change in haematocrit

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing haematocrit during rest, exercise and recovery in the two groups

  19. Change in differential blood count

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing differential blood count during rest, exercise and recovery in the two groups

  20. Change in plasma IL-6 concentration

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing plasma IL-6 concentration during rest, exercise and recovery in the two groups

  21. Change in plasma TNF-alpha concentration

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing plasma TNF-alpha concentration during rest, exercise and recovery in the two groups

  22. Change in plasma IL-8 concentration

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing plasma IL-8 concentration during rest, exercise and recovery in the two groups

  23. Change in plasma IL-10 concentration

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing plasma IL-10 concentration during rest, exercise and recovery in the two groups

  24. Change in plasma IL-1beta concentration

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing plasma IL-1beta concentration during rest, exercise and recovery in the two groups

  25. Change in plasma IL-1Ra concentration

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing plasma IL-1Ra concentration during rest, exercise and recovery in the two groups

  26. Change in plasma IL-4 concentration

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing plasma IL-4 concentration during rest, exercise and recovery in the two groups

  27. Change in plasma sIL-6R concentration

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing plasma sIL-6R concentration during rest, exercise and recovery in the two groups

  28. Change in insulin

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing insulin during rest, exercise and recovery in the two groups

  29. Change in c-peptide

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing c-peptide during rest, exercise and recovery in the two groups

  30. Change in glucagon

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing glucagon during rest, exercise and recovery in the two groups

  31. Change in growth hormone (GH)

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing GH during rest, exercise and recovery in the two groups

  32. Change in adrenaline

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing adrenaline during rest, exercise and recovery in the two groups

  33. Change in noradrenaline

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing noradrenaline during rest, exercise and recovery in the two groups

  34. Change in cortisol

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing cortisol during rest, exercise and recovery in the two groups

  35. Change in total glucagon-like peptide-1 (GLP-1)

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing total GLP-1 during rest, exercise and recovery in the two groups

  36. Change in active GLP-1

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing active GLP-1 during rest, exercise and recovery in the two groups

  37. Change in gastric inhibitory peptide (GIP)

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing GIP during rest, exercise and recovery in the two groups

  38. Change in peptide YY (PYY)

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing PYY during rest, exercise and recovery in the two groups

  39. Change in leptin

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing leptin during rest, exercise and recovery in the two groups

  40. Change in triglycerides

    Time frame: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

    Comparing triglycerides during rest, exercise and recovery in the two groups

Other outcomes

  1. Change in muscle total antioxidant capacity (TAC)

    Time frame: Measured in muscle biopsies taken at 0, 120 and 360 minutes

    Comparing muscle total antioxidant capacity (TAC) at rest, after exercise and recovery in the two groups

  2. Change in muscle superoxide levels (SOD)

    Time frame: Measured in muscle biopsies taken at 0, 120 and 360 minutes

    Comparing muscle superoxide levels (SOD) at rest, after exercise and recovery in the two groups

  3. Excess post-exercise oxygen consumption

    Time frame: Measured at -130, 0, 60, 120, 180, 240, 300 and 360 minutes

    Comparing excess post-exercise oxygen consumption between the two groups

Sponsors and collaborators

Lead sponsor

Helga Ellingsgaard

Other

Registry information

Official study title

Role of IL-6 in Regulating Energy Stores During Recovery From an Acute Exercise Bout

Acronym: REX-6

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Oct 26, 2022

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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