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临床试验/NCT03201276
NCT03201276Unknown不适用

Individual Differences in Glucosamine Sulfate Exposure Levels and Related Gene Polymorphism Research

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School0 个研究点目标入组 400 人开始时间: 2017年7月2日最近更新:
适应症
干预措施
相关药物

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

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

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qing Jiang

Vice Dean

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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