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IL-6 Regulation of Energy Stores During Recovery From an Acute Exercise Bout (REX-6)

25 ottobre 2022 aggiornato da: Helga Ellingsgaard

Role of IL-6 in Regulating Energy Stores During Recovery From an Acute Exercise Bout

The aim of the study is to investigate the role of exercise-induced IL-6 in regulating energy stores and energy metabolism during recovery after an acute exercise bout. To achieve this, 30 men will be randomized to infusion placebo or tocilizumab (IL-6 receptor antibody) combined with a 2-hour exercise bout. Stable isotope tracers will be infused to determine substrate kinetics. Indirect calorimetry will be applied to determine substrate oxidation, and muscle biopsies will be taken to determine substrate uptake and storage.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Danimarca
    • Capital Region
      • Copenhagen, Capital Region, Danimarca, 2100
        • Centre for Physical Activity Research, Rigshospitalet Section 7641

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 40 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • Physically active (defined as meeting the ACSM's guidelines of 2.5h per week of moderate to vigorous physical activity per week), young, healthy males will be included. Participants may be included in the study if they meet all the following criteria:

    • Age ≥ 18 years and ≤ 40 years
    • BMI < 18 and > 25 kg/m2
    • Healthy (based on screening)
    • Stable body weight for 6 months
    • ≥ 2.5h/week moderate to vigorous physical activity

Exclusion Criteria:

  • • Cardiovascular disease

    • Rheumatologic disease
    • Metabolic disease
    • Elite sports or high aerobic training status (VO2max > 60 mL O2/min/kg)
    • Frequent/chronic use of medications affecting physical performance or inflammation (NSAIDS, DMARDS, corticosteroids)
    • Aspirin use >100 mg/d
    • Thyroid disease
    • Current infection
    • Aspartate amino transferase (AST) or alanine amino transferase (ALT) >2x upper normal range
    • History of carcinoma
    • History of tuberculosis
    • Ketogenic diet
    • Smoking
    • Anemia (hematocrit <33%)
    • Neutrophil count <0,5x 109/l
    • Thrombocytes <50x 109/l or bleeding disorders

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Tocilizumab
Participants will receive one 30 min intravenous infusion of tocilizumab/Actemra® (Roche). The dose will be 8 mg/kg bodyweight or a maximum of 800mg. Tocilizumab is dissolved in 100 mL 0.9% saline.
Droga: Tocilizumab/Actemra® (Roche)
The infusion of tocilizumab will antagonize IL-6 signaling for the duration of the study, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise
Comparatore placebo: Saline
As placebo, participants will receive one 30 min intravenous infusion of 100 mL 0.9% saline.
Droga: Saline 9%
The infusion of saline will serve as placebo for tocilizumab, allowing us to determine the role of IL-6 in regulating energy stores following acute exercise

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in muscle glycogen content (mmol/kg/h)
Lasso di tempo: Measured at 0, 120, 180 and 360 minutes
Comparing change in muscle glycogen in the two groups from before exercise to immediately after exercise, and after 1 hour and 4 hours of recovery
Measured at 0, 120, 180 and 360 minutes
Change in muscle triglycerides content
Lasso di tempo: Measured at 0, 120, 180 and 360 minutes
Comparing change in muscle triglycerides in the two groups from before exercise to immediately after exercise, and after 1 hour and 4 hours of recovery
Measured at 0, 120, 180 and 360 minutes
Change in muscle expression of glucose transporter type 4 (GLUT4)
Lasso di tempo: Measured at 0, 120 and 360 min
Comparing muscle expression of GLUT4 before and immediately after exercise and 4 hours after recovery in the two groups
Measured at 0, 120 and 360 min
Change in muscle expression of fatty acid translocase (FAT/CD36)
Lasso di tempo: Measured at 0, 120 and 360 min
Comparing muscle expression of FAT/CD36 before and immediately after exercise and 4 hours after recovery in the two groups
Measured at 0, 120 and 360 min
Change in muscle expression of muscle fatty acid binding protein (FABPm)
Lasso di tempo: Measured at 0, 120 and 360 min
Comparing muscle expression of FABPm before and immediately after exercise and 4 hours after recovery in the two groups
Measured at 0, 120 and 360 min
Change in muscle expression of fatty acid transporter 4 (FATP4)
Lasso di tempo: Measured at 0, 120 and 360 min
Comparing muscle expression of FATP4 before and immediately after exercise and 4 hours after recovery in the two groups
Measured at 0, 120 and 360 min
Change in muscle expression of glycerol transporters
Lasso di tempo: Measured at 0, 120 and 360 min
Comparing muscle expression of glycerol transporters before and immediately after exercise and 4 hours after recovery in the two groups
Measured at 0, 120 and 360 min

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in glucose rate of appearance
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing glucose rate of appearance during exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucose rate of disappearance
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing glucose rate of disappearance during exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucose concentration
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing glucose concentration during exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucose enrichment in intramuscular glycogen
Lasso di tempo: Measured at 0, 120, 180 and 360 minutes
Comparing glucose enrichment in intramuscular glycogen during rest, exercise and recovery in the two groups
Measured at 0, 120, 180 and 360 minutes
Change in intramuscular glucose concentration
Lasso di tempo: Measured at 0, 120, 180 and 360 minutes
Comparing intramuscular glucose concentration during rest, exercise and recovery in the two groups
Measured at 0, 120, 180 and 360 minutes
Change in glycogen fractional synthesis rate
Lasso di tempo: Measured at 0, 120, 180 and 360 minutes
Comparing intramuscular glycogen fractional synthesis rate during rest, exercise and recovery in the two groups
Measured at 0, 120, 180 and 360 minutes
Change in gylcerol rate of appearance
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing gylcerol rate of appearance during rest, exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in gylcerol rate of disappearance
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing gylcerol rate of disappearance during rest, exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in gylcerol concentration
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing gylcerol concentration during rest, exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate rate of appearance
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing palmitate rate of appearance during rest, exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate rate of disappearance
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing palmitate rate of disappearance during rest, exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate concentration
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing palmitate kinetics during rest, exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in palmitate oxidation
Lasso di tempo: Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing palmitate oxidation during rest, exercise and recovery in the two groups
Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in intramuscular palmitate content
Lasso di tempo: Measured at 0, 120, 180 and 360 minutes
Comparing intramuscular palmitate content during rest, exercise and recovery in the two groups
Measured at 0, 120, 180 and 360 minutes
Change in palmitate enrichment in intramuscular triglycerides
Lasso di tempo: Measured at 0, 120, 180 and 360 minutes
Comparing palmitate enrichment in intramuscular triglycerides during rest, exercise and recovery in the two groups
Measured at 0, 120, 180 and 360 minutes
Change in intramuscular triglycerides fractional synthesis rate
Lasso di tempo: Measured at 0, 120, 180 and 360 minutes
Comparing intramuscular triglycerides fractional synthesis rate during rest, exercise and recovery in the two groups
Measured at 0, 120, 180 and 360 minutes
Change in haemoglobin
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing haemoglobin during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in haematocrit
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing haematocrit during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in differential blood count
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing differential blood count during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-6 concentration
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing plasma IL-6 concentration during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma TNF-alpha concentration
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing plasma TNF-alpha concentration during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-8 concentration
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing plasma IL-8 concentration during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-10 concentration
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing plasma IL-10 concentration during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-1beta concentration
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing plasma IL-1beta concentration during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-1Ra concentration
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing plasma IL-1Ra concentration during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma IL-4 concentration
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing plasma IL-4 concentration during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in plasma sIL-6R concentration
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing plasma sIL-6R concentration during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in insulin
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing insulin during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in c-peptide
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing c-peptide during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in glucagon
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing glucagon during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in growth hormone (GH)
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing GH during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in adrenaline
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing adrenaline during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in noradrenaline
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing noradrenaline during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in cortisol
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing cortisol during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in total glucagon-like peptide-1 (GLP-1)
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing total GLP-1 during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in active GLP-1
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing active GLP-1 during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in gastric inhibitory peptide (GIP)
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing GIP during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in peptide YY (PYY)
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing PYY during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in leptin
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing leptin during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Change in triglycerides
Lasso di tempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
Comparing triglycerides during rest, exercise and recovery in the two groups
Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in muscle total antioxidant capacity (TAC)
Lasso di tempo: Measured in muscle biopsies taken at 0, 120 and 360 minutes
Comparing muscle total antioxidant capacity (TAC) at rest, after exercise and recovery in the two groups
Measured in muscle biopsies taken at 0, 120 and 360 minutes
Change in muscle superoxide levels (SOD)
Lasso di tempo: Measured in muscle biopsies taken at 0, 120 and 360 minutes
Comparing muscle superoxide levels (SOD) at rest, after exercise and recovery in the two groups
Measured in muscle biopsies taken at 0, 120 and 360 minutes
Excess post-exercise oxygen consumption
Lasso di tempo: Measured at -130, 0, 60, 120, 180, 240, 300 and 360 minutes
Comparing excess post-exercise oxygen consumption between the two groups
Measured at -130, 0, 60, 120, 180, 240, 300 and 360 minutes

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Helga Ellingsgaard

Investigatori

  • Cattedra di studio: Bente K Pedersen, MD, Rigshospitalet, Denmark

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 aprile 2022

Completamento primario (Effettivo)

11 ottobre 2022

Completamento dello studio (Effettivo)

11 ottobre 2022

Date di iscrizione allo studio

Primo inviato

6 aprile 2022

Primo inviato che soddisfa i criteri di controllo qualità

21 aprile 2022

Primo Inserito (Effettivo)

27 aprile 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 ottobre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 ottobre 2022

Ultimo verificato

1 ottobre 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • H-21063697

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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