IL-6 Regulation of Energy Stores During Recovery From an Acute Exercise Bout (REX-6)
2022년 10월 25일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Capital Region
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Copenhagen, Capital Region, 덴마크, 2100
- Centre for Physical Activity Research, Rigshospitalet Section 7641
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in muscle glycogen content (mmol/kg/h)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in glucose rate of appearance
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
|
Change in glucagon
기간: 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)
기간: 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
기간: 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
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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 noradrenaline
기간: 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
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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 cortisol
기간: 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
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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 total glucagon-like peptide-1 (GLP-1)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
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Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
|
|
Change in triglycerides
기간: Measured at -150, -30, 10, 30, 60, 90, 120, 130, 150, 180, 210, 240, 300 and 360 minutes
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Comparing triglycerides 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in muscle total antioxidant capacity (TAC)
기간: 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
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Measured in muscle biopsies taken at 0, 120 and 360 minutes
|
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Change in muscle superoxide levels (SOD)
기간: Measured in muscle biopsies taken at 0, 120 and 360 minutes
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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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Bente K Pedersen, MD, Rigshospitalet, Denmark
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 4월 20일
기본 완료 (실제)
2022년 10월 11일
연구 완료 (실제)
2022년 10월 11일
연구 등록 날짜
최초 제출
2022년 4월 6일
QC 기준을 충족하는 최초 제출
2022년 4월 21일
처음 게시됨 (실제)
2022년 4월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 10월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 10월 25일
마지막으로 확인됨
2022년 10월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- H-21063697
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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미국 FDA 규제 기기 제품 연구
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .