Healthy Volunteers OnlyEVEXNCT06334653
Exercise-regulated Organ Crosstalk, Influence of IL-6
A study testing exercise in people with Healthy Volunteers Only and Energy Metabolism, run by Helga Ellingsgaard at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Healthy Volunteers Only, Energy Metabolism
- What is being tested?
- exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Apr 2024to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Smoking
- Thyroid disease
- Heart disease
- Inflammatory diseases
- Current infection
- Liver disease (transaminases more than 2x upper normal range)
Show all 23Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Volunteers Only, Energy Metabolism
- Being tested
- exercise
- Keywords
- tocilizumab, exercise, IL-6, extracellular vesicles, energy, muscle, liver, brain
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
acute exercise bout
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline infusion Receives: Other: exercise |
| Tocilizumab | Experimental | IL-6 receptor antibody infusion (8 mg/kg body weight, max 800 mg) Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
Number of EVs from muscle, liver, and brain.
Comparing the number of EVs deriving from skeletal muscle, liver, and brain.
Measured: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
Size of EVs from muscle, liver, and brain.
Comparing EV size deriving from skeletal muscle, liver, and brain.
Measured: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
EVs from muscle, liver, and brain.
Comparing the content of EVs deriving from skeletal muscle, liver, and brain.
Measured: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
Influence of exercise on EV number.
Comparing the number of EVs deriving from skeletal muscle, liver, and brain in response to exercise.
Measured: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
Influence of exercise on EV size
Comparing EV size deriving from skeletal muscle, liver, and brain in response to exercise.
Measured: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
Influence of exercise on EV content.
Comparing the content of EVs deriving from skeletal muscle, liver, and brain in response to exercise.
Measured: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
Tissue specific proteomic content of EVs.
Comparing differences in proteomic content of EVs from skeletal muscle, liver, and brain in response to exercise.
Measured: Comparisons between placebo and IL-6R ab are done at the end of a 1-hour exercise bout (330 minutes).
Secondary outcomes (12)
Lactate.
Differences in plasma lactate from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.
Measured: 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).
Pyruvate.
Differences in plasma pyruvate from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.
Measured: 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).
Keto acids.
Differences in plasma keto acids from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.
Measured: 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).
Ketone bodies.
Differences in plasma ketone bodies from skeletal muscle, liver, and brain comparing placebo and IL-6R ab.
Measured: 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).
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.
Measured: 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).
Influence of IL-6 on insulin.
Comparing differences in plasma insulin concentrations between placebo and IL-6R ab.
Measured: 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).
Influence of IL-6 on glucagon.
Comparing differences plasma glucagon concentrations between placebo and IL-6R ab.
Measured: 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).
Influence of IL-6 on epinephrine.
Comparing differences in plasma epinephrine concentrations between placebo and IL-6R ab.
Measured: 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).
Influence of IL-6 on norepinephrine.
Comparing differences in plasma norepinephrine concentrations between placebo and IL-6R ab.
Measured: 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).
IL-6 levels.
Comparing differences in plasma IL-6 concentrations between placebo and IL-6R ab.
Measured: 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).
Influence of IL-6 on substrate usage.
Differences in respiratory exchange ratio comparing placebo and IL-6R ab.
Measured: 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).
Influence of IL-6 on perceived exertion.
Differences in rate of perceived exertion during exercise comparing placebo and IL-6R ab.
Measured: Comparisons between placebo and IL-6R ab are done during exercise (time points 285, 300, 315, and 330 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start9 Apr 2024
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helga Ellingsgaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Helga Ellingsgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Helga Ellingsgaard, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334653
- Sponsor's protocol ID
- H-23069670
- Acronym
- EVEX
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hvidemose JO, Trinh B, Vassilieva A, Fenger AW, Bjerring PN, van Hall M, Clemmesen JO, Sigurethsson SThorn, Moller K, van Hall G, Febbraio MA, Pedersen BK, Plomgaard P, Ellingsgaard H. Autocrine Signaling may Regulate Exercise-Induced Interleukin-6 Release from Human Skeletal Muscle. Mol Metab. 2026 Sep 18:102441. doi: 10.1016/j.molmet.2026.102441. Online ahead of print.
PubMed 42759885
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-regulated Organ Crosstalk, Influence of IL-6
- ClinicalTrials.gov ID
- NCT06334653
- Acronym / sponsor ID
- EVEX / H-23069670
- Conditions
- Healthy Volunteers Only, Energy Metabolism
- Keywords
- tocilizumab, exercise, IL-6, extracellular vesicles, energy, muscle, liver, brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Helga EllingsgaardUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: exerciseSaline infusion |
| Tocilizumab | Experimental | Other: exerciseIL-6 receptor antibody infusion (8 mg/kg body weight, max 800 mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Minimum age: 18 years
- Maximum age: 45 years
- Minimum BMI: 18
- Maximum BMI: 25
- Sex: Male
Key exclusion criteria (23 listed)
- Smoking
- Thyroid disease
- Heart disease
- Inflammatory diseases
- Current infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseacute exercise bout | Other | Placebo, Tocilizumab |
Primary outcome
Whole body substrate kinetics.
Time frame: 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).
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.
Tissue specific utilization and production of substrates.
Time frame: 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).
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.
IL-6 regulation of protein synthesis and degradation.
Time frame: 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).
Comparing differences in protein synthesis and degradation rates between placebo and IL-6Rab at rest, during exercise, and during recovery from exercise.
Number of EVs from muscle, liver, and brain.
Time frame: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
Comparing the number of EVs deriving from skeletal muscle, liver, and brain.
Size of EVs from muscle, liver, and brain.
Time frame: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
Comparing EV size deriving from skeletal muscle, liver, and brain.
EVs from muscle, liver, and brain.
Time frame: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
Comparing the content of EVs deriving from skeletal muscle, liver, and brain.
Influence of exercise on EV number.
Time frame: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
Comparing the number of EVs deriving from skeletal muscle, liver, and brain in response to exercise.
Influence of exercise on EV size
Time frame: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
Comparing EV size deriving from skeletal muscle, liver, and brain in response to exercise.
Influence of exercise on EV content.
Time frame: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).
Comparing the content of EVs deriving from skeletal muscle, liver, and brain in response to exercise.
Tissue specific proteomic content of EVs.
Time frame: Comparisons between placebo and IL-6R ab are done at the end of a 1-hour exercise bout (330 minutes).
Comparing differences in proteomic content of EVs from skeletal muscle, liver, and brain in response to exercise.
12 secondary outcomes
Lactate.
Time frame: 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).
Pyruvate.
Time frame: 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).
Keto acids.
Time frame: 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).
Ketone bodies.
Time frame: 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).
Influence of IL-6 on fatty acid oxidation rates.
Time frame: 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).
Influence of IL-6 on insulin.
Time frame: 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).
Influence of IL-6 on glucagon.
Time frame: 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).
Influence of IL-6 on epinephrine.
Time frame: 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).
Influence of IL-6 on norepinephrine.
Time frame: 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).
IL-6 levels.
Time frame: 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).
Influence of IL-6 on substrate usage.
Time frame: 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).
Influence of IL-6 on perceived exertion.
Time frame: Comparisons between placebo and IL-6R ab are done during exercise (time points 285, 300, 315, and 330 minutes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 42759885Hvidemose JO, Trinh B, Vassilieva A, Fenger AW, Bjerring PN, van Hall M, Clemmesen JO, Sigurethsson SThorn, Moller K, van Hall G, Febbraio MA, Pedersen BK, Plomgaard P, Ellingsgaard H. Autocrine Signaling may Regulate Exercise-Induced Interleukin-6 Release from Human Skeletal Muscle. Mol Metab. 2026 Sep 18:102441. doi: 10.1016/j.molmet.2026.102441. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helga Ellingsgaard, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Healthy Volunteers Only and Energy Metabolism, run by Helga Ellingsgaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body substrate kinetics. (time frame: 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).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.