此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study (Chäs2)

2018年1月25日 更新者：University Hospital, Basel, Switzerland

Role of IL-1 in Postprandial Fatigue - The Chäschüechli 2 Study

Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single dose, placebo-controlled, double blind, cross-over, proof-of-concept study.

16 healthy young men will be included in this study. The objective of this study is to evaluate if severity of postprandial fatigue is driven by IL-1.

Since fatigue is associated with increased cytokine levels, and since fatigue in chronic inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β, postprandial fatigue might also respond to anti-inflammatory intervention with IL-1 inhibition.

The aim of the study is to investigate whether postprandial fatigue is, at least in part, driven by the IL-1 system.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

16

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

  • 瑞士
      • Basel、瑞士、CH-4031 Basel
        • University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism

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

20年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

Male subjects

  • non-smoking
  • apparently healthy
  • BMI >18 and ≤28 kg/m2 or BMI >30 and ≤35 kg/m2
  • Age 20-65 years
  • Subject is usually eating breakfast and lunch
  • Willingness to use contraceptive measures adequate to prevent the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD) and sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner).
  • Owner of a smartphone so they will be able to download and use the sleeping APP, Sleep cycle, prior to the study days.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

  • Night shift workers
  • Subjects suffering from sleep disturbances
  • Clinical signs of infection in the week before inclusion or history of infection during the last 2 months (CRP >5mg/l)
  • Impaired fasting glucose (fasting plasma glucose >5.5mmol/l)
  • Hematologic disease (leukocyte count < 1.5x109/l, hemoglobin <11 g/dl, platelets <100 x 103/ul)
  • Kidney disease (creatinine > 1.5 mg/dl))
  • Liver disease (transaminases >2x upper normal range)
  • Heart disease
  • Pulmonary disease
  • Inflammatory disease
  • History of carcinoma
  • History of tuberculosis
  • Alcohol consumption >40g/d
  • Smoking
  • Known allergy towards Kineret
  • Known allergy to ingredients of the test meal
  • Current treatment with any drug in the week before inclusion, including vitamin supplementation (especially vitamin C and E)
  • Use of any investigational drug within 30 days prior to enrolment or within 5 half-lives of the investigational drug, whichever is longer
  • Subject refusing or unable to give written informed consent

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：其他
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Normal BMI
Healthy young men, normal BMI (BMI >18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl)
药品：Anakinra
Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
其他名称：
  • Kineret
药品：NaCl
subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
其他名称：
  • 氯化钠
实验性的：Overweight
Healthy young men (BMI >30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl
药品：Anakinra
Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
其他名称：
  • Kineret
药品：NaCl
subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
其他名称：
  • 氯化钠

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
The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo
大体时间：7 to 9 days (change between study day 1 and study day 2)
Fatigue will be measured by using the SSS (Stanford Sleepiness Scale)
7 to 9 days (change between study day 1 and study day 2)

次要结果测量

结果测量
措施说明
大体时间
Change in postprandial glucose, insulin, C-peptide, glucagon-like Peptide (GLP)-1(active/total), GIP(active/total), PYY, IL-6, tumor necrosis factor (TNF)-alfa, sCRP and cortisol due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in heart rate due to any treatment (Anakinra vs. saline)
大体时间：7 to 9 days (change between study day 1 and study day 2)
Pulse watch
7 to 9 days (change between study day 1 and study day 2)
Change in insulin due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in C-peptide due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in GLP-1(active/total) due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in GIP(active/total) due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in PYY due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in IL-6 due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in TNF-alfa due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in sCRP due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)
Change in cortisol due to any treatment (Anakinra vs. saline).
大体时间：7 to 9 days (change between study day 1 and study day 2)
Blood sampling
7 to 9 days (change between study day 1 and study day 2)

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。

赞助

University Hospital, Basel, Switzerland

合作者

Rigshospitalet, Denmark

调查人员

  • 首席研究员：Marc Y Donath, MD、University Hospital, Basel, Switzerland

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

2016年8月1日

初级完成 (实际的)

2017年4月1日

研究完成 (实际的)

2017年4月3日

研究注册日期

首次提交

2016年9月26日

首先提交符合 QC 标准的

2016年9月26日

首次发布 (估计)

2016年9月27日

研究记录更新

最后更新发布 (实际的)

2018年1月29日

上次提交的符合 QC 标准的更新

2018年1月25日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • EKNZ BASEC 2016-00816

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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.

订阅