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临床试验/NCT06334653
NCT06334653已完成不适用

Exercise-regulated Organ Crosstalk, Influence of IL-6

Helga Ellingsgaard1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Tissue specific proteomic content of EVs.

研究概览

简要总结

Overall the study investigates organ crosstalk during exercise. More specifically, the study investigates the role of IL-6 in regulating glucose, fatty acid, and amino acid kinetics at whole body level and in skeletal muscle, liver, and brain. Furthermore, the study investigates the uptake and release of extracellular vesicles in skeletal muscle, liver, and brain in reponse to exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Minimum age: 18 years
  • Maximum age: 45 years
  • Minimum BMI: 18
  • Maximum BMI: 25
  • Sex: Male
  • Healthy (based on screening)
  • Stable body weight for 6 months
  • VO2max (mL/kg/min) ≥ 50

排除标准

  • Thyroid disease
  • Heart disease
  • Inflammatory diseases
  • Current infection
  • Liver disease (transaminases more than 2x upper normal range)
  • Kidney disease (creatinine more than1.5 mg/dl)
  • Known immunosuppressive disease
  • Corticosteroid use
  • Regular NSAID or paracetamol usage
  • Aspirin use more than 100 mg/d
  • History of carcinoma
  • History of tuberculosis
  • Anemia (hematocrit less than 33%)
  • WBC less than 1 x 10^3
  • Platelets less than 100 x 10^3
  • Bleeding disorders
  • Obstructive pulmonary disease
  • Femoral hernia
  • Vascular prosthesis
  • Vascular thrombosis
  • Previous nerve damage
  • Many previous femoral catheter installations

结局指标

主要结局

Tissue specific proteomic content of EVs.

时间窗: Comparisons between placebo and IL-6R ab are done at the end of a 1-hour exercise bout (330 minutes).

Comparing differences in proteomic content of EVs from skeletal muscle, liver, and brain in response to exercise.

Tissue specific utilization and production of substrates.

时间窗: Comparisons between study arms are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).

Comparing, between placebo and IL-6Rab, by measuring in plasma, the Ra and Rd of substrates in muscle, liver, and brain at rest, during exercise, and recovery using the non-steady-state equations of Steele adapted for stable isotopes.

IL-6 regulation of protein synthesis and degradation.

时间窗: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).

Comparing differences in protein synthesis and degradation rates between placebo and IL-6Rab at rest, during exercise, and during recovery from exercise.

Size of EVs from muscle, liver, and brain.

时间窗: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).

Comparing EV size deriving from skeletal muscle, liver, and brain.

EVs from muscle, liver, and brain.

时间窗: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).

Comparing the content of EVs deriving from skeletal muscle, liver, and brain.

Influence of exercise on EV content.

时间窗: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).

Comparing the content of EVs deriving from skeletal muscle, liver, and brain in response to exercise.

Influence of exercise on EV size

时间窗: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).

Comparing EV size deriving from skeletal muscle, liver, and brain in response to exercise.

Whole body substrate kinetics.

时间窗: Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).

Comparing rates of appearances (Ra) and disappearances (Rd) of glucose, glycerol, palmitate, amino acids between placebo and IL-6R ab at rest, during exercise, and recovery.

Number of EVs from muscle, liver, and brain.

时间窗: Comparisons between placebo and IL-6R ab are done before exercise (time points 255 and 270 minutes).

Comparing the number of EVs deriving from skeletal muscle, liver, and brain.

Influence of exercise on EV number.

时间窗: Comparisons between placebo and IL-6R ab are done throughout a 1-hour exercise bout (time points 285, 300, 315, and 330 minutes).

Comparing the number of EVs deriving from skeletal muscle, liver, and brain in response to exercise.

次要结局

  • Lactate.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • Pyruvate.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • Ketone bodies.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • Influence of IL-6 on glucagon.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • Influence of IL-6 on norepinephrine.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • IL-6 levels.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • Keto acids.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • Influence of IL-6 on perceived exertion.(Comparisons between placebo and IL-6R ab are done during exercise (time points 285, 300, 315, and 330 minutes).)
  • Influence of IL-6 on fatty acid oxidation rates.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • Influence of IL-6 on insulin.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • Influence of IL-6 on epinephrine.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)
  • Influence of IL-6 on substrate usage.(Comparisons between placebo and IL-6R ab are done at rest (time points 255 and 270 minutes), during exercise (time points 285, 300, 315, and 330 minutes) and during recovery from exercise (time points 345, 360, and 390 minutes).)

研究者

发起方
Helga Ellingsgaard
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Helga Ellingsgaard

Principle Investigator

Rigshospitalet, Denmark

研究点 (1)

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