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

Helga Ellingsgaard

Status: Completed

Conditions: Glycogen Depletion

Treatments: Drug: Saline 9%; Drug: Tocilizumab/Actemra® (Roche)

Study type: Interventional

Funder types: Other

Identifiers

NCT05349149

H-21063697

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Tocilizumab

Experimental group

Description:

Participants will receive one 30 min intravenous infusion of tocilizumab/Actemra® (Roche). The dose will be 8 mg/kg bodyweight or a maximum of 800mg. Tocilizumab is dissolved in 100 mL 0.9% saline.

Treatment:

Drug: Tocilizumab/Actemra® (Roche)

Saline

Placebo Comparator group

Description:

As placebo, participants will receive one 30 min intravenous infusion of 100 mL 0.9% saline.

Treatment:

Drug: Saline 9%