Individual Differences in Glucosamine Sulfate Exposure Levels

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Glucosamine Sulfate

• Registration Number: NCT03201276
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Status Verified: 2017-07
• Study Start: 2017-07-02
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05
• Primary Completion: 2019-07-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug group	Glucosamine Sulfate	patients taking glucosamine

Primary Outcome Measures

Name	Time	Method
Drug concentration in synovial fluid	During the operation of total knee arthroplasty	Drug concentration is measured by HPLC-MS/MS
Inflammatory markers in plasma	During the operation of total knee arthroplasty	ADAM-TS5
Drug concentration in plasma	Venous blood during the operation of total knee arthroplasty	Drug concentration is measured by HPLC-MS/MS
Inflammatory markers in synovial fluid	During the operation of total knee arthroplasty	ADAM-TS5
Gene polymorphism	Fasting venous blood before the first administration	Gene polymorphisms of glucosamine transporters in vivo