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Individual Differences in Glucosamine Sulfate Exposure Levels

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03201276
Enrollment
400
Registered
2017-06-28
Start date
2017-07-02
Completion date
2019-10-01
Last updated
2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

glucosamine sulfate, individual differences, gene polymorphism

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.

Interventions

Patients taking glucosamine sulfate 1500mg every day for at least four days.

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Drug concentration in plasmaFasting venous blood before the first administrationDrug concentration is measured by HPLC-MS/MS
Drug concentration in synovial fluidDuring the operation of total knee arthroplastyDrug concentration is measured by HPLC-MS/MS
Inflammatory markers in plasmaFasting venous blood before the first administrationLeptin
Inflammatory markers in synovial fluidDuring the operation of total knee arthroplastyLeptin
Gene polymorphismFasting venous blood before the first administrationGene polymorphisms of glucosamine transporters in vivo

Contacts

Primary ContactQing Jiang
qingj@nju.edu.cn+8613605192953
Backup ContactRuijuan Xu
jean0129@163.com+8613851502360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026