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

25. oktober 2022 opdateret af: 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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
30

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: 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.
Medicin: 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
Placebo komparator: Saline
As placebo, participants will receive one 30 min intravenous infusion of 100 mL 0.9% saline.
Medicin: 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

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in muscle glycogen content (mmol/kg/h)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in glucose rate of appearance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in muscle total antioxidant capacity (TAC)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Helga Ellingsgaard

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Studiestol: Bente K Pedersen, MD, Rigshospitalet, Denmark

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
20. april 2022

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
11. oktober 2022

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
11. oktober 2022

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
6. april 2022

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
21. april 2022

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
27. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
26. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
25. oktober 2022

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • H-21063697

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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