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

NCT ID: NCT05349149

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2022-10-11

Brief Summary

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.

Conditions

Glycogen Depletion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Tocilizumab

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.

Group Type: EXPERIMENTAL

Tocilizumab/Actemra® (Roche)

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Saline 9%

Intervention Type: 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

Interventions

Tocilizumab/Actemra® (Roche)

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

Intervention Type: DRUG

Saline 9%

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Helga Ellingsgaard

OTHER

Sponsor Role: lead

Responsible Party

Helga Ellingsgaard

PhD, Group leader, Centre for Physical Activity Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bente K Pedersen, MD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Centre for Physical Activity Research, Rigshospitalet Section 7641

Copenhagen, Capital Region, Denmark

Countries

Denmark

Other Identifiers

H-21063697

Identifier Type: -

Identifier Source: org_study_id