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Individual Differences in Glucosamine Sulfate Exposure Levels

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

キーワード

概要

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.

日付

最終確認済み: 06/30/2017
最初に提出された: 06/22/2017
提出された推定登録数: 06/26/2017
最初の投稿: 06/27/2017
最終更新が送信されました: 07/02/2017
最終更新日: 07/04/2017
実際の研究開始日: 07/01/2017
一次完了予定日: 06/30/2019
研究完了予定日: 09/30/2019

状態または病気

Knee Osteoarthritis

介入/治療

Drug: Drug group

段階

-

アームグループ

介入/治療
Drug group
patients taking glucosamine
Drug: Drug group
Patients taking glucosamine sulfate 1500mg every day for at least four days.

適格基準

研究の対象となる年齢 60 Years に 60 Years
研究に適格な性別All
サンプリング方法Non-Probability Sample
健康なボランティアを受け入れるはい
基準

Inclusion Criteria:

1. patients undergoing total knee arthroplasty for knee osteoarthritis;

2. 60-80 years.

Exclusion Criteria:

1. patients with severe liver or renal insufficiency;

2. patients allergic to glucosamine or any excipients in tablets;

3. patients who have been treated with glucosamine within three months;

4. patients who are unable to cooperate with the study;

5. continuous medication is less than 4 days;

6. patients with diarrhea, vomiting and other adverse reactions during medication.

結果

主な結果の測定

1. Drug concentration in plasma [Fasting venous blood before the first administration]

Drug concentration is measured by HPLC-MS/MS

2. Drug concentration in plasma [3 hours after the third administration]

Drug concentration is measured by HPLC-MS/MS

3. Drug concentration in plasma [9 hours after the third administration]

Drug concentration is measured by HPLC-MS/MS

4. Drug concentration in plasma [Fasting venous blood before the fourth administration]

Drug concentration is measured by HPLC-MS/MS

5. Drug concentration in plasma [Venous blood during the operation of total knee arthroplasty]

Drug concentration is measured by HPLC-MS/MS

6. Drug concentration in synovial fluid [During the operation of total knee arthroplasty]

Drug concentration is measured by HPLC-MS/MS

7. Inflammatory markers in plasma [Fasting venous blood before the first administration]

Leptin

8. Inflammatory markers in plasma [3 hours after the third administration]

Leptin

9. Inflammatory markers in plasma [9 hours after the third administration]

Leptin

10. Inflammatory markers in plasma [Fasting venous blood before the fourth administration]

Leptin

11. Inflammatory markers in plasma [During the operation of total knee arthroplasty]

Leptin

12. Inflammatory markers in plasma [Fasting venous blood before the first administration]

IL-1β

13. Inflammatory markers in plasma [3 hours after the third administration]

IL-1β

14. Inflammatory markers in plasma [9 hours after the third administration]

IL-1β

15. Inflammatory markers in plasma [Fasting venous blood before the fourth administration]

IL-1β

16. Inflammatory markers in plasma [During the operation of total knee arthroplasty]

IL-1β

17. Inflammatory markers in plasma [Fasting venous blood before the first administration]

COX-2

18. Inflammatory markers in plasma [3 hours after the third administration]

COX-2

19. Inflammatory markers in plasma [9 hours after the third administration]

COX-2

20. Inflammatory markers in plasma [Fasting venous blood before the fourth administration]

COX-2

21. Inflammatory markers in plasma [During the operation of total knee arthroplasty]

COX-2

22. Inflammatory markers in plasma [Fasting venous blood before the first administration]

IL-6

23. Inflammatory markers in plasma [3 hours after the third administration]

IL-6

24. Inflammatory markers in plasma [9 hours after the third administration]

IL-6

25. Inflammatory markers in plasma [Fasting venous blood before the fourth administration]

IL-6

26. Inflammatory markers in plasma [During the operation of total knee arthroplasty]

IL-6

27. Inflammatory markers in plasma [Fasting venous blood before the first administration]

TNFα

28. Inflammatory markers in plasma [3 hours after the third administration]

TNFα

29. Inflammatory markers in plasma [9 hours after the third administration]

TNFα

30. Inflammatory markers in plasma [Fasting venous blood before the fourth administration]

TNFα

31. Inflammatory markers in plasma [During the operation of total knee arthroplasty]

TNFα

32. Inflammatory markers in plasma [Fasting venous blood before the first administration]

MMP-3

33. Inflammatory markers in plasma [3 hours after the third administration]

MMP-3

34. Inflammatory markers in plasma [9 hours after the third administration]

MMP-3

35. Inflammatory markers in plasma [Fasting venous blood before the fourth administration]

MMP-3

36. Inflammatory markers in plasma [During the operation of total knee arthroplasty]

MMP-3

37. Inflammatory markers in plasma [Fasting venous blood before the first administration]

ADAM-TS5

38. Inflammatory markers in plasma [3 hours after the third administration]

ADAM-TS5

39. Inflammatory markers in plasma [9 hours after the third administration]

ADAM-TS5

40. Inflammatory markers in plasma [Fasting venous blood before the fourth administration]

ADAM-TS5

41. Inflammatory markers in plasma [During the operation of total knee arthroplasty]

ADAM-TS5

42. Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]

Leptin

43. Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]

IL-1β

44. Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]

COX-2

45. Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]

IL-6

46. Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]

TNFα

47. Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]

MMP-3

48. Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]

ADAM-TS5

49. Gene polymorphism [Fasting venous blood before the first administration]

Gene polymorphisms of glucosamine transporters in vivo

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