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.
調査の概要
研究の種類
介入
入学 (実際)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
Capital Region
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Copenhagen、Capital Region、デンマーク、2100
- Centre for Physical Activity Research, Rigshospitalet Section 7641
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～40年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in muscle glycogen content (mmol/kg/h)
時間枠：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
|
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Change in muscle triglycerides content
時間枠：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
|
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Change in muscle expression of glucose transporter type 4 (GLUT4)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in glucose rate of appearance
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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
時間枠：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
|
|
Change in insulin
時間枠：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
|
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Change in c-peptide
時間枠：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
時間枠：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)
時間枠：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
|
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
時間枠：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
|
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Change in noradrenaline
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
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Change in gastric inhibitory peptide (GIP)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in muscle total antioxidant capacity (TAC)
時間枠：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)
時間枠：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
|
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Excess post-exercise oxygen consumption
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Bente K Pedersen, MD、Rigshospitalet, Denmark
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年4月20日
一次修了 (実際)
2022年10月11日
研究の完了 (実際)
2022年10月11日
試験登録日
最初に提出
2022年4月6日
QC基準を満たした最初の提出物
2022年4月21日
最初の投稿 (実際)
2022年4月27日
学習記録の更新
投稿された最後の更新 (実際)
2022年10月26日
QC基準を満たした最後の更新が送信されました
2022年10月25日
最終確認日
2022年10月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- H-21063697
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。