NL-OMON36944撤回不适用
Ex vivo LPS stimulation in healthy and compromised subjects - Ex vivo LPS stimulation study
TNO0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- aged 35 to 45 years, on study day 1
- •- Healthy voluenteers are defined based on medical history evaluation, physical examination, results of the pre-study laboratory tests and a health and lifestyle questionnaire, with following criteria: HbA1c <= 5.5% (37 mmol/mol) or fasting glucose >= 3.4 and <= 5.6 mmol/L ; further the waist circumference < 94 cm; and body fat percentage between 8-24.9%.
- •-The prediabetics with overweight meet the following criteria: HbA1c in the range of 6.0 - 6.5% (42 - 48mmol/mol) Or fasting glucose in the range of 6.1-6.9 mmol/L; further the waist circumference >= 102 cm; and body fat percentage >= 25 %.
排除标准
- •-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;
- •-Use of any medication 14 days before day 01; use of paracetamol 7 days before day 01.
- •-Currently smoking or stopped smoking less than 6 months ago
- •-Alcohol consumption >= 21 units per week
- •-Exercise more than five hours per week
- •-Use of dietary supplements (e.g. fish oil capsules, polyphenols and vitamins)
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