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

September 30, 2024 updated by: Helga Ellingsgaard
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Saline infusion
Other: exercise
acute exercise bout
Experimental: Tocilizumab
IL-6 receptor antibody infusion (8 mg/kg body weight, max 800 mg)
Other: exercise
acute exercise bout

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
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.
Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).
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.
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
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.
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.
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.
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.
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.
Comparisons between placebo and IL-6R ab are done at the end of a 1-hour exercise bout (330 minutes).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Whole body/liver fractional synthesis rates of both the very low-density lipoproteins fat and protein part (TAG and apolipoprotein B100)
Time Frame: Information will be obtained at rest (time points 255 and 270 min), during exercise (time points 285, 300, 315, and 330 min) and during recovery from exercise (time points 345, 360, and 390 min).
Information will be obtained at rest (time points 255 and 270 min), during exercise (time points 285, 300, 315, and 330 min) and during recovery from exercise (time points 345, 360, and 390 min).
Differences in concentrations as well as fractional synthesis rate of 24 plasma 'fat' proteins (all apolipoprotein, albumin, transthyretin and enzymes related to high density lipoprotein formation comparing IL-6R ab to placebo).
Time Frame: Comparisons between study arms are made at rest (time points 255 and 270 min), during exercise (time points 285, 300, 315, and 330 min) and during recovery from exercise (time points 345, 360, and 390 min).
Comparisons between study arms are made at rest (time points 255 and 270 min), during exercise (time points 285, 300, 315, and 330 min) and during recovery from exercise (time points 345, 360, and 390 min).
Detailed information on alanine/glutamate/leucine interactive metabolism and their role in gluconeogenesis at the level of whole body and in skeletal muscle, liver, and brain.
Time Frame: Information will be obtained at rest (time points 255 and 270 min), during exercise (time points 285, 300, 315, and 330 min) and during recovery from exercise (time points 345, 360, and 390 min).
Information will be obtained at rest (time points 255 and 270 min), during exercise (time points 285, 300, 315, and 330 min) and during recovery from exercise (time points 345, 360, and 390 min).
Detailed information on whole body, skeletal muscle, liver, and brain arginine, ornithine, and citrulline metabolism and quantitative total nitric oxide (NO) production rates.
Time Frame: Information will be obtained at rest (time points 255 and 270 min), during exercise (time points 285, 300, 315, and 330 min) and during recovery from exercise (time points 345, 360, and 390 min).
Information will be obtained at rest (time points 255 and 270 min), during exercise (time points 285, 300, 315, and 330 min) and during recovery from exercise (time points 345, 360, and 390 min).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helga Ellingsgaard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Helga Ellingsgaard, PhD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-23069670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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