Ex Vivo LPS Stimulation in Healthy and Compromised Subjects
Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an inflammatory response and examine differences in the inflammatory response between healthy and compromised subjects.
The purpose of the current study is to examine the inflammatory response in a younger population (35-45 yrs old) to see whether in this population also differences in the ex vivo LPS induced cytokine response exists between healthy and compromised subjects, as is seen in elderly subjects. Overweight subjects showing a state of disturbed blood glucose control will be included as subjects with compromised health and compared to healthy lean subjects with the same age (shifting from healthy towards unhealthy, not diseased).
Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory cytokine response in a healthy population that is different from a response of the compromised population. The investigators will include subjects aged 35-45 years that differ in health characteristics, especially blood HbA1c, fat% and waist circumference.
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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Zuid-Holland
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Leiden、Zuid-Holland、荷兰、2333 CH
- CHDR
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests;
- Males aged between 35-45 years;
- Waist circumference: healthy < 94 cm, compromised ≥ 102 cm.
- Body composition (InBody 720): body fat % healthy men < 8-19% %; for compromised men > 25%;
- HbA1c levels for healthy subjects < 5.5 % or fasting glucose > 3.4 or < 5.6 mmol/L; for compromised HbA1c >=6 and< 6.5% or fasting glucose between 6.1-6.9 mmol/L;
- Regular Dutch eating habits as assessed (three main meals, including bread) by health and lifestyle questionnaires.
Exclusion Criteria:
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study;
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances;
- Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder or inflammatory diseases or allergy;
- Use of any medication within 14 days before day 01; use of paracetamol within 7 days before day 01;
- Currently smoking or stopped smoking less than 6 months ago;
- Alcohol consumption >= 21 units per week;
- Performing more than 5 hour sports activity per week;
- Use of dietary supplements that could affect the inflammatory response (eg fish oil, polyphenols, vitamins);
- Not having a general practitioner;
- Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner;
- Not willing to give permission to have the general practitioner to be notified upon participation in this study.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Healthy men
Healthy male subjects with normal weight
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Compromised men
pre-diabetic overweight, male subjects
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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 |
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Cytokines
大体时间:baseline, 4h and 24h incubation with ex vivo LPS
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The levels of interleukines present in healthy and compromised subjects will be determined in a baseline sample.
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baseline, 4h and 24h incubation with ex vivo LPS
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合作者和调查者
赞助
调查人员
- 首席研究员:Pierre Peeters, PhD、CHDR Leiden
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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