Exercise-regulated Organ Crosstalk, Influence of IL-6 (EVEX)

Helga Ellingsgaard

Status: Completed

Conditions: Energy Metabolism; Healthy Volunteers Only

Treatments: Other: exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06334653

H-23069670

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

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

Placebo

Placebo Comparator group

Description:

Saline infusion

Treatment:

Other: exercise

Tocilizumab

Experimental group

Description:

IL-6 receptor antibody infusion (8 mg/kg body weight, max 800 mg)

Treatment:

Other: exercise