Individual Differences in Glucosamine Sulfate Exposure Levels and Related Gene Polymorphism Research
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 主要终点
- Drug concentration in plasma
研究概览
简要总结
Glucosamine is an important part of the treatment strategy for osteoarthritis, but its effectiveness is still controversial. To explain the efficacy differences of glucosamine, in this study the investigators detect the concentration of glucosamine in the plasma and synovial fluid, some effect indexes such as inflammatory markers and gene polymorphism of glucosamine transporters. On the one hand, the investigators compare the plasma peak and gluten glucosamine concentration and the concentration in synovial fluid among participants to observe the individual differences of glucosamine exposure in vivo. On the other hand, the investigators investigate the correlation between drug concentrations, effect index and gene polymorphism. The hypothesis is that glucosamine exposure in vivo has individual differences and gene polymorphism can explain this differences.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing total knee arthroplasty for knee osteoarthritis;
- •60-80 years.
排除标准
- •patients with severe liver or renal insufficiency;
- •patients allergic to glucosamine or any excipients in tablets;
- •patients who have been treated with glucosamine within three months;
- •patients who are unable to cooperate with the study;
- •continuous medication is less than 4 days;
- •patients with diarrhea, vomiting and other adverse reactions during medication.
研究组 & 干预措施
Drug group
patients taking glucosamine
干预措施: Glucosamine Sulfate (Drug)
结局指标
主要结局
Drug concentration in plasma
时间窗: Venous blood during the operation of total knee arthroplasty
Drug concentration is measured by HPLC-MS/MS
Drug concentration in synovial fluid
时间窗: During the operation of total knee arthroplasty
Drug concentration is measured by HPLC-MS/MS
Inflammatory markers in plasma
时间窗: During the operation of total knee arthroplasty
ADAM-TS5
Inflammatory markers in synovial fluid
时间窗: During the operation of total knee arthroplasty
ADAM-TS5
Gene polymorphism
时间窗: Fasting venous blood before the first administration
Gene polymorphisms of glucosamine transporters in vivo
次要结局
未报告次要终点
研究者
Qing Jiang
Vice Dean
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
