Role of IL-1 in Postprandial Fatigue - The Chäschüechli 2 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
Normal BMI
Healthy young men, normal BMI (BMI >18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl)
干预措施: Anakinra (Drug)
Normal BMI
Healthy young men, normal BMI (BMI >18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl)
干预措施: NaCl (Drug)
Overweight
Healthy young men (BMI >30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl
干预措施: Anakinra (Drug)
Overweight
Healthy young men (BMI >30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl
干预措施: NaCl (Drug)
结局指标
主要结局
The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo
时间窗: 7 to 9 days (change between study day 1 and study day 2)
Fatigue will be measured by using the SSS (Stanford Sleepiness Scale)
次要结局
- 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).(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).(7 to 9 days (change between study day 1 and study day 2))
- Change in PYY due to any treatment (Anakinra vs. saline).(7 to 9 days (change between study day 1 and study day 2))
- Change in cortisol due to any treatment (Anakinra vs. saline).(7 to 9 days (change between study day 1 and study day 2))
- Change in C-peptide due to any treatment (Anakinra vs. saline).(7 to 9 days (change between study day 1 and study day 2))
- Change in heart rate due to any treatment (Anakinra vs. saline)(7 to 9 days (change between study day 1 and study day 2))
- Change in insulin due to any treatment (Anakinra vs. saline).(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).(7 to 9 days (change between study day 1 and study day 2))
- Change in IL-6 due to any treatment (Anakinra vs. saline).(7 to 9 days (change between study day 1 and study day 2))
- Change in TNF-alfa due to any treatment (Anakinra vs. saline).(7 to 9 days (change between study day 1 and study day 2))
- Change in sCRP due to any treatment (Anakinra vs. saline).(7 to 9 days (change between study day 1 and study day 2))