IL-6 Regulation of Energy Stores During Recovery From an Acute Exercise Bout (REX-6)
2022年10月25日 更新者：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.
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
Capital Region
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Copenhagen、Capital Region、丹麦、2100
- Centre for Physical Activity Research, Rigshospitalet Section 7641
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
不
有资格学习的性别
男性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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安慰剂比较：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in muscle glycogen content (mmol/kg/h)
大体时间：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
|
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Change in muscle triglycerides content
大体时间：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
|
Measured at 0, 120, 180 and 360 minutes
|
|
Change in muscle expression of glucose transporter type 4 (GLUT4)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in glucose rate of appearance
大体时间：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
大体时间：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
大体时间：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
|
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Change in glucose enrichment in intramuscular glycogen
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
|
Change in gylcerol rate of disappearance
大体时间：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
大体时间：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
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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
大体时间：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
大体时间：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
|
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Change in palmitate concentration
大体时间：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
大体时间：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
大体时间：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
|
Measured at 0, 120, 180 and 360 minutes
|
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Change in palmitate enrichment in intramuscular triglycerides
大体时间：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
|
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Change in intramuscular triglycerides fractional synthesis rate
大体时间：Measured at 0, 120, 180 and 360 minutes
|
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
大体时间：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
|
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
大体时间：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
|
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
大体时间：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
|
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Change in plasma IL-6 concentration
大体时间：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
|
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Change in plasma TNF-alpha concentration
大体时间：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
|
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
大体时间：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
|
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Change in plasma IL-10 concentration
大体时间：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
|
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Change in plasma IL-1beta concentration
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
|
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Change in cortisol
大体时间：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)
大体时间：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
|
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Change in active GLP-1
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in muscle total antioxidant capacity (TAC)
大体时间：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)
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Bente K Pedersen, MD、Rigshospitalet, Denmark
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年4月20日
初级完成 (实际的)
2022年10月11日
研究完成 (实际的)
2022年10月11日
研究注册日期
首次提交
2022年4月6日
首先提交符合 QC 标准的
2022年4月21日
首次发布 (实际的)
2022年4月27日
研究记录更新
最后更新发布 (实际的)
2022年10月26日
上次提交的符合 QC 标准的更新
2022年10月25日
最后验证
2022年10月1日
更多信息
与本研究相关的术语
其他研究编号
- H-21063697
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.