IL-6 Regulation of Energy Stores During Recovery From an Acute Exercise Bout (REX-6)
25 de octubre de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Capital Region
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Copenhagen, Capital Region, Dinamarca, 2100
- Centre for Physical Activity Research, Rigshospitalet Section 7641
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 40 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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
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Comparador de placebos: Saline
As placebo, participants will receive one 30 min intravenous infusion of 100 mL 0.9% saline.
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in muscle glycogen content (mmol/kg/h)
Periodo de tiempo: Measured at 0, 120, 180 and 360 minutes
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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
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Change in muscle triglycerides content
Periodo de tiempo: Measured at 0, 120, 180 and 360 minutes
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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
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Measured at 0, 120, 180 and 360 minutes
|
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Change in muscle expression of glucose transporter type 4 (GLUT4)
Periodo de tiempo: Measured at 0, 120 and 360 min
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Comparing muscle expression of GLUT4 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 fatty acid translocase (FAT/CD36)
Periodo de tiempo: Measured at 0, 120 and 360 min
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Comparing muscle expression of FAT/CD36 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 muscle fatty acid binding protein (FABPm)
Periodo de tiempo: Measured at 0, 120 and 360 min
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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
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Change in muscle expression of fatty acid transporter 4 (FATP4)
Periodo de tiempo: Measured at 0, 120 and 360 min
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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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in glucose rate of appearance
Periodo de tiempo: 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 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
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Change in glucose rate of disappearance
Periodo de tiempo: 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 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
Periodo de tiempo: 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 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
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Change in glucose enrichment in intramuscular glycogen
Periodo de tiempo: Measured at 0, 120, 180 and 360 minutes
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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
Periodo de tiempo: Measured at 0, 120, 180 and 360 minutes
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 disappearance 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 concentration
Periodo de tiempo: 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 concentration 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 rate of appearance
Periodo de tiempo: 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 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 palmitate rate of disappearance
Periodo de tiempo: 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 rate of disappearance 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 concentration
Periodo de tiempo: 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 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
Periodo de tiempo: 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
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Change in intramuscular palmitate content
Periodo de tiempo: Measured at 0, 120, 180 and 360 minutes
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Comparing intramuscular palmitate content 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 palmitate enrichment in intramuscular triglycerides
Periodo de tiempo: Measured at 0, 120, 180 and 360 minutes
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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
Periodo de tiempo: Measured at 0, 120, 180 and 360 minutes
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Comparing intramuscular triglycerides 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 haemoglobin
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Change in plasma IL-6 concentration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Change in plasma IL-1Ra concentration
Periodo de tiempo: 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-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
Periodo de tiempo: 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-4 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 sIL-6R concentration
Periodo de tiempo: 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
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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 insulin
Periodo de tiempo: 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
|
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Change in c-peptide
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing c-peptide 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 glucagon
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing glucagon 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 growth hormone (GH)
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing GH 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 adrenaline
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
|
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Change in noradrenaline
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
|
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Change in cortisol
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
|
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Change in total glucagon-like peptide-1 (GLP-1)
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing total GLP-1 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 active GLP-1
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing active GLP-1 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 gastric inhibitory peptide (GIP)
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing GIP 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 peptide YY (PYY)
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing PYY 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 leptin
Periodo de tiempo: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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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
|
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Change in triglycerides
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in muscle total antioxidant capacity (TAC)
Periodo de tiempo: 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
|
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Change in muscle superoxide levels (SOD)
Periodo de tiempo: 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
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Measured in muscle biopsies taken at 0, 120 and 360 minutes
|
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Excess post-exercise oxygen consumption
Periodo de tiempo: 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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Bente K Pedersen, MD, Rigshospitalet, Denmark
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de abril de 2022
Finalización primaria (Actual)
11 de octubre de 2022
Finalización del estudio (Actual)
11 de octubre de 2022
Fechas de registro del estudio
Enviado por primera vez
6 de abril de 2022
Primero enviado que cumplió con los criterios de control de calidad
21 de abril de 2022
Publicado por primera vez (Actual)
27 de abril de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de octubre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
25 de octubre de 2022
Última verificación
1 de octubre de 2022
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- H-21063697
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .