Individual Differences in Glucosamine Sulfate Exposure Levels

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Glucosamine Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing total knee arthroplasty for knee osteoarthritis; 60-80 years. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Drug group<br>patients taking glucosamine | Drug: Glucosamine Sulfate<br>* Patients taking glucosamine sulfate 1500mg every day for at least four days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug concentration in plasma | Drug concentration is measured by HPLC-MS/MS | Fasting venous blood before the first administration | 
| Drug concentration in plasma | Drug concentration is measured by HPLC-MS/MS | 3 hours after the third administration | 
| Drug concentration in plasma | Drug concentration is measured by HPLC-MS/MS | 9 hours after the third administration | 
| Drug concentration in plasma | Drug concentration is measured by HPLC-MS/MS | Fasting venous blood before the fourth administration | 
| Drug concentration in plasma | Drug concentration is measured by HPLC-MS/MS | Venous blood during the operation of total knee arthroplasty | 
| Drug concentration in synovial fluid | Drug concentration is measured by HPLC-MS/MS | During the operation of total knee arthroplasty | 
| Inflammatory markers in plasma | Leptin | Fasting venous blood before the first administration | 
| Inflammatory markers in plasma | Leptin | 3 hours after the third administration | 
| Inflammatory markers in plasma | Leptin | 9 hours after the third administration | 
| Inflammatory markers in plasma | Leptin | Fasting venous blood before the fourth administration | 
| Inflammatory markers in plasma | Leptin | During the operation of total knee arthroplasty | 
| Inflammatory markers in plasma | IL-1β | Fasting venous blood before the first administration | 
| Inflammatory markers in plasma | IL-1β | 3 hours after the third administration | 
| Inflammatory markers in plasma | IL-1β | 9 hours after the third administration | 
| Inflammatory markers in plasma | IL-1β | Fasting venous blood before the fourth administration | 
| Inflammatory markers in plasma | IL-1β | During the operation of total knee arthroplasty | 
| Inflammatory markers in plasma | COX-2 | Fasting venous blood before the first administration | 
| Inflammatory markers in plasma | COX-2 | 3 hours after the third administration | 
| Inflammatory markers in plasma | COX-2 | 9 hours after the third administration | 
| Inflammatory markers in plasma | COX-2 | Fasting venous blood before the fourth administration | 
| Inflammatory markers in plasma | COX-2 | During the operation of total knee arthroplasty | 
| Inflammatory markers in plasma | IL-6 | Fasting venous blood before the first administration | 
| Inflammatory markers in plasma | IL-6 | 3 hours after the third administration | 
| Inflammatory markers in plasma | IL-6 | 9 hours after the third administration | 
| Inflammatory markers in plasma | IL-6 | Fasting venous blood before the fourth administration | 
| Inflammatory markers in plasma | IL-6 | During the operation of total knee arthroplasty | 
| Inflammatory markers in plasma | TNFα | Fasting venous blood before the first administration | 
| Inflammatory markers in plasma | TNFα | 3 hours after the third administration | 
| Inflammatory markers in plasma | TNFα | 9 hours after the third administration | 
| Inflammatory markers in plasma | TNFα | Fasting venous blood before the fourth administration | 
| Inflammatory markers in plasma | TNFα | During the operation of total knee arthroplasty | 
| Inflammatory markers in plasma | MMP-3 | Fasting venous blood before the first administration | 
| Inflammatory markers in plasma | MMP-3 | 3 hours after the third administration | 
| Inflammatory markers in plasma | MMP-3 | 9 hours after the third administration | 
| Inflammatory markers in plasma | MMP-3 | Fasting venous blood before the fourth administration | 
| Inflammatory markers in plasma | MMP-3 | During the operation of total knee arthroplasty | 
| Inflammatory markers in plasma | ADAM-TS5 | Fasting venous blood before the first administration | 
| Inflammatory markers in plasma | ADAM-TS5 | 3 hours after the third administration | 
| Inflammatory markers in plasma | ADAM-TS5 | 9 hours after the third administration | 
| Inflammatory markers in plasma | ADAM-TS5 | Fasting venous blood before the fourth administration | 
| Inflammatory markers in plasma | ADAM-TS5 | During the operation of total knee arthroplasty | 
| Inflammatory markers in synovial fluid | Leptin | During the operation of total knee arthroplasty | 
| Inflammatory markers in synovial fluid | IL-1β | During the operation of total knee arthroplasty | 
| Inflammatory markers in synovial fluid | COX-2 | During the operation of total knee arthroplasty | 
| Inflammatory markers in synovial fluid | IL-6 | During the operation of total knee arthroplasty | 
| Inflammatory markers in synovial fluid | TNFα | During the operation of total knee arthroplasty | 
| Inflammatory markers in synovial fluid | MMP-3 | During the operation of total knee arthroplasty | 
| Inflammatory markers in synovial fluid | ADAM-TS5 | During the operation of total knee arthroplasty | 
| Gene polymorphism | Gene polymorphisms of glucosamine transporters in vivo | Fasting venous blood before the first administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucosamine sulfate, individual differences, gene polymorphism