Exercise-regulated Organ Crosstalk, Influence of IL-6

NCT ID: NCT06334653

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-09

Study Completion Date

2024-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers Only Energy Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Saline infusion

Group Type PLACEBO_COMPARATOR

exercise

Intervention Type OTHER

acute exercise bout

Tocilizumab

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

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

acute exercise bout

Interventions

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exercise

acute exercise bout

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Helga Ellingsgaard

OTHER

Sponsor Role lead

Responsible Party

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Helga Ellingsgaard

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Helga Ellingsgaard, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-23069670

Identifier Type: -

Identifier Source: org_study_id

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