Exercise-regulated Organ Crosstalk, Influence of IL-6

Energy Metabolism Clinical Trial

— EVEX  

Official title:

Exercise-regulated Organ Crosstalk, Influence of IL-6

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334653
• Other study ID #: H-23069670
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Helga Ellingsgaaard, PhD
• Phone: +4535457641
• Email: helga.ellingsgaard[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Energy Metabolism
• Healthy Volunteers Only

Intervention

Other:
• exercise
acute exercise bout

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Helga Ellingsgaard

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body substrate kinetics.	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.	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).
Primary	Tissue specific utilization and production of substrates.	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.	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).
Primary	IL-6 regulation of protein synthesis and degradation.	Comparing differences in protein synthesis and degradation rates between placebo and IL-6Rab at rest, during exercise, and during recovery from exercise.	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).
Primary	Number of EVs from muscle, liver, and brain.	Comparing the number of EVs deriving from skeletal muscle, liver, and brain.	Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
Primary	Size of EVs from muscle, liver, and brain.	Comparing EV size deriving from skeletal muscle, liver, and brain.	Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
Primary	EVs from muscle, liver, and brain.	Comparing the content of EVs deriving from skeletal muscle, liver, and brain.	Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
Primary	Influence of exercise on EV number.	Comparing the number of EVs deriving from skeletal muscle, liver, and brain in response to exercise.	Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
Primary	Influence of exercise on EV size	Comparing EV size deriving from skeletal muscle, liver, and brain in response to exercise.	Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
Primary	Influence of exercise on EV content.	Comparing the content of EVs deriving from skeletal muscle, liver, and brain in response to exercise.	Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
Primary	Tissue specific proteomic content of EVs.	Comparing differences in proteomic content of EVs from skeletal muscle, liver, and brain in response to exercise.	Comparisons between placebo and IL-6R ab are done at the end of a 1-hour exercise bout (330 minutes).
Secondary	Lactate.	Differences in plasma lactate from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.	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).
Secondary	Pyruvate.	Differences in plasma pyruvate from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.	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).
Secondary	Keto acids.	Differences in plasma keto acids from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.	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).
Secondary	Ketone bodies.	Differences in plasma ketone bodies from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.	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).
Secondary	Influence of IL-6 on fatty acid oxidation rates.	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.	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).
Secondary	Influence of IL-6 on insulin.	Comparing differences in plasma insulin concentrations between placebo and IL-6R ab.	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).
Secondary	Influence of IL-6 on glucagon.	Comparing differences plasma glucagon concentrations between placebo and IL-6R ab.	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).
Secondary	Influence of IL-6 on epinephrine.	Comparing differences in plasma epinephrine concentrations between placebo and IL-6R ab.	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).
Secondary	Influence of IL-6 on norepinephrine.	Comparing differences in plasma norepinephrine concentrations between placebo and IL-6R ab.	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).
Secondary	IL-6 levels.	Comparing differences in plasma IL-6 concentrations between placebo and IL-6R ab.	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).
Secondary	Influence of IL-6 on substrate usage.	Differences in respiratory exchange ratio comparing placebo and IL-6R ab.	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).
Secondary	Influence of IL-6 on perceived exertion.	Differences in rate of perceived exertion during exercise comparing placebo and IL-6R ab.	Comparisons between placebo and IL-6R ab are done during exercise (time points 285, 300, 315, and 330 minutes).