Characterization of Natural IL-6 Inhibition in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Whole-body glucose metabolism
研究概览
简要总结
The aim of the project is to investigate whether or not there are any difference in cardiometabolic outcomes in individuals with high or low levels of c-aAb against interleukin-6 (IL-6).
The study is the first to investigate individuals with extreme amounts of c-aAb levels against IL-6 and to contribute with knowledge on a possible new phenotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fulfill Danish blood donor criteria
- •Have extreme amounts of IL-6 c-aAb or matched as control (low amounts of IL-6 c-aAb)
排除标准
- •Failure to fulfill Danish blood donor criteria
研究组 & 干预措施
High IL-6 c-aAb
Individuals with top percentile IL-6 c-aAb
干预措施: Oral Glucose Tolerance Test (Other)
High IL-6 c-aAb
Individuals with top percentile IL-6 c-aAb
干预措施: Cycling test (Other)
Low IL-6 c-aAb
Individually matched controls with low IL-6 c-aAb
干预措施: Oral Glucose Tolerance Test (Other)
Low IL-6 c-aAb
Individually matched controls with low IL-6 c-aAb
干预措施: Cycling test (Other)
结局指标
主要结局
Whole-body glucose metabolism
时间窗: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Plasma levels of: Insulin
Cardiovascular risk markers
时间窗: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
Lipids
Difference in exercise response
时间窗: Measurements over a two-hour cycling test, and one hour of recovery
2-hour Lactate
Metabolic response during exercise
时间窗: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
2-hour glucose
Metabolic assessment of the liver
时间窗: An MRI-scanning withinn four weeks of the oral glucose tolerance test
Liver fat content from MRI-scanning, and HOMA-IR
Inflammatory markers
时间窗: Measurements over a three-hour oral glucose tolerance test, a two-hour cycling test, and one hour of recovery
IL-6 plasma levels, plasma IL-6 c-aAb levels
次要结局
未报告次要终点
研究者
Torben Hansen
Professor
University of Copenhagen