- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05349149
IL-6 Regulation of Energy Stores During Recovery From an Acute Exercise Bout (REX-6)
25. oktober 2022 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Capital Region
-
Copenhagen, Capital Region, Danmark, 2100
- Centre for Physical Activity Research, Rigshospitalet Section 7641
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 40 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
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.
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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
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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
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Measured at 0, 120 and 360 min
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Change in muscle expression of glycerol transporters
Tidsramme: Measured at 0, 120 and 360 min
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Comparing muscle expression of glycerol transporters before and immediately after exercise and 4 hours after recovery in the two groups
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Measured at 0, 120 and 360 min
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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
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Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
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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
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Measured at 0, 120, 180 and 360 minutes
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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
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Measured at 0, 120, 180 and 360 minutes
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Change in glycogen fractional synthesis rate
Tidsramme: Measured at 0, 120, 180 and 360 minutes
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Comparing intramuscular glycogen fractional synthesis rate during rest, exercise and recovery in the two groups
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Measured at 0, 120, 180 and 360 minutes
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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
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Comparing gylcerol rate of appearance during rest, exercise and recovery in the two groups
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Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
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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
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Measured at -150, -60, -45, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
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Comparing palmitate oxidation during rest, exercise and recovery in the two groups
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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
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Measured at 0, 120, 180 and 360 minutes
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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
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Change in haemoglobin
Tidsramme: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing haemoglobin during rest, exercise and recovery in the two groups
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Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Change in haematocrit
Tidsramme: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing haematocrit during rest, exercise and recovery in the two groups
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Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Change in differential blood count
Tidsramme: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing differential blood count during rest, exercise and recovery in the two groups
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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
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Comparing plasma IL-6 concentration during rest, exercise and recovery in the two groups
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Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
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Comparing plasma TNF-alpha concentration during rest, exercise and recovery in the two groups
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Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
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Comparing plasma IL-8 concentration during rest, exercise and recovery in the two groups
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Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
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Comparing plasma IL-10 concentration during rest, exercise and recovery in the two groups
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Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
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Comparing plasma IL-1beta concentration during rest, exercise and recovery in the two groups
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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
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Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
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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
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Change in insulin
Tidsramme: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing insulin during rest, exercise and recovery in the two groups
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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
Resultatmål |
Tiltaksbeskrivelse |
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
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Measured at -130, 0, 60, 120, 180, 240, 300 and 360 minutes
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Bente K Pedersen, MD, Rigshospitalet, Denmark
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. april 2022
Primær fullføring (Faktiske)
11. oktober 2022
Studiet fullført (Faktiske)
11. oktober 2022
Datoer for studieregistrering
Først innsendt
6. april 2022
Først innsendt som oppfylte QC-kriteriene
21. april 2022
Først lagt ut (Faktiske)
27. april 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. oktober 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. oktober 2022
Sist bekreftet
1. oktober 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- H-21063697
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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