NCT06721910已完成不适用
Interplay Between Interleukin-6 and Glucagon in the Regulation of Human Amino Acid and Protein Homeostasis
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年1月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in maximum glucagon-induced reduction in total plasma amino acid concentrations
研究概览
简要总结
The goal of this proof-of-concept study is to learn if interleukin-6 changes the effect of glucagon in healthy volunteers. The main question it aims to answer is:
Does IL-6 influence how effectively glucagon lowers the concentration of amino acids in blood? Researchers will compare the infusion of normal saline and a blocker of the receptor for interleukin-6 to see if blocking interluekin-6 changes how effectively glucagon lowers the concentration of amino acids in blood.
Participants will be asked to
- receive either an infusion of normal saline or the interleukin-6 receptor blocker
- participate in a study visit three weeks later at which they will receive infusions of hormones and amino acids to mimic the concentrations of the hormones insulin and glucagon during fasting or fed conditions
- labelled glucose, glycerol and amino acids will also be infused continuously to track the fate of these molecules
- during the hormone infusions blood samples will be taken repeatedly
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
Infusion of 100 ml normal saline
干预措施: Placebo (Other)
IL-6R ab
Active Comparator
Infusion of tocilizumab, 8mg/kg body weight or max. 800mg in 100 ml normal saline
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Change in maximum glucagon-induced reduction in total plasma amino acid concentrations
时间窗: At visit 2 during high glucagon phase (80-120 minutes)
次要结局
- AUC of total amino acids(At visit 2 during high glucagon phase (80-120 minutes))
- rate of phenylalanine oxidation(At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes))
- urea concentrations(At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes))
- rate of gluconeogenesis from amino acids(At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes))
- fractional synthesis rate of plasma proteins(At visit 2 (60, 180, 300 minutes))
- Amino acid uptake by PBMCs ex vivo(At visit 1 and visit 2 (-120 minutes))
- Change in fractional synthesis rate of lipoproteins(At visit 2 (60, 180, 300 minutes))
- Cytokine plasma concentrations (IL-6, IL-1RA, TNF-alpha, IL-8, IL-10, CRP)(At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes))
- Plasma concentrations of insulin, c-peptide, glucagon, GH, IGF-1, cortisol, catecholamines, fT4, fT3, FGF21, follistatin, AGPTL4, ketones(At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes))
- Energy expenditure kcal/24 hours(At visit 2 (40, 160, 280 minutes))
- Respiratory exchange rate(At visit 2 (40, 160, 280 minutes))
- Oxygen consumption (VO2 ml/minutes)(At visit 2 (40, 160, 280 minutes))
- Carbondioxid production (VCO2 ml/minutes)(At visit 2 (40, 160, 280 minutes))
- Body composition (lean body mass kg)(At visit 1 and 2 (-120 minutes))
- Body composition (fat bodymass kg)(At visit 1 and 2 (-120 minutes))
- Blood pressure systolic(At visit 2 (-120 minutes))
- Blood pressure diastolic(At visit 2 (-120 minutes))
- Heart rate(At visit 2 (-120minutes))
研究者
研究点 (1)
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