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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

Kľúčové slová

Abstrakt

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.

Termíny

Naposledy overené: 06/30/2017
Prvý príspevok: 06/22/2017
Odhadovaná registrácia bola odoslaná: 06/26/2017
Prvý príspevok: 06/27/2017
Posledná aktualizácia bola odoslaná: 07/02/2017
Posledná aktualizácia bola zverejnená: 07/04/2017
Aktuálny dátum začatia štúdie: 07/01/2017
Odhadovaný dátum dokončenia primárneho okruhu: 06/30/2019
Odhadovaný dátum dokončenia štúdie: 09/30/2019

Stav alebo choroba

Knee Osteoarthritis

Intervencia / liečba

Drug: Drug group

Fáza

-

Skupiny zbraní

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

Kritériá oprávnenosti

Vek vhodný na štúdium 60 Years To 60 Years
Pohlavia vhodné na štúdiumAll
Metóda vzorkovaniaNon-Probability Sample
Prijíma zdravých dobrovoľníkovÁno
Kritériá

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.

Výsledok

Primárne výstupné opatrenia

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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