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

25 października 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 40 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Męski

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: 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
Komparator placebo: Saline
As placebo, participants will receive one 30 min intravenous infusion of 100 mL 0.9% saline.
Lek: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in muscle glycogen content (mmol/kg/h)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in glucose rate of appearance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in muscle total antioxidant capacity (TAC)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Helga Ellingsgaard

Śledczy

  • Krzesło do nauki: Bente K Pedersen, MD, Rigshospitalet, Denmark

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 kwietnia 2022

Zakończenie podstawowe (Rzeczywisty)

11 października 2022

Ukończenie studiów (Rzeczywisty)

11 października 2022

Daty rejestracji na studia

Pierwszy przesłany

6 kwietnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 kwietnia 2022

Pierwszy wysłany (Rzeczywisty)

27 kwietnia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 października 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 października 2022

Ostatnia weryfikacja

1 października 2022

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • H-21063697

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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