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Knee OsteoarthritisNCT03201276

Individual Differences in Glucosamine Sulfate Exposure Levels

An observational study of Knee Osteoarthritis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Glucosamine Sulfate
How many people
400 participants
Where
No sites listed yet
Study dates
2 Jul 2017to 1 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing total knee arthroplasty for knee osteoarthritis

Who may be able to join

  • patients undergoing total knee arthroplasty for knee osteoarthritis;
  • 60-80 years.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Qing Jiang contact

+8613605192953

qingj@nju.edu.cn

Ruijuan Xu contact

+8613851502360

jean0129@163.com

About this study

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

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.

Being tested
Glucosamine Sulfate
Keywords
glucosamine sulfate, individual differences, gene polymorphism
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glucosamine SulfateDrug

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

Study groups in NCT03201276
Study groupRoleWhat they receive
Drug grouppatients taking glucosamine
Receives: Drug: Glucosamine Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug concentration in plasma

    Drug concentration is measured by HPLC-MS/MS

    Measured: Fasting venous blood before the first administration

  2. Drug concentration in plasma

    Drug concentration is measured by HPLC-MS/MS

    Measured: 3 hours after the third administration

  3. Drug concentration in plasma

    Drug concentration is measured by HPLC-MS/MS

    Measured: 9 hours after the third administration

  4. Drug concentration in plasma

    Drug concentration is measured by HPLC-MS/MS

    Measured: Fasting venous blood before the fourth administration

  5. Drug concentration in plasma

    Drug concentration is measured by HPLC-MS/MS

    Measured: Venous blood during the operation of total knee arthroplasty

  6. Drug concentration in synovial fluid

    Drug concentration is measured by HPLC-MS/MS

    Measured: During the operation of total knee arthroplasty

  7. Inflammatory markers in plasma

    Leptin

    Measured: Fasting venous blood before the first administration

  8. Inflammatory markers in plasma

    Leptin

    Measured: 3 hours after the third administration

  9. Inflammatory markers in plasma

    Leptin

    Measured: 9 hours after the third administration

  10. Inflammatory markers in plasma

    Leptin

    Measured: Fasting venous blood before the fourth administration

  11. Inflammatory markers in plasma

    Leptin

    Measured: During the operation of total knee arthroplasty

  12. Inflammatory markers in plasma

    IL-1β

    Measured: Fasting venous blood before the first administration

  13. Inflammatory markers in plasma

    IL-1β

    Measured: 3 hours after the third administration

  14. Inflammatory markers in plasma

    IL-1β

    Measured: 9 hours after the third administration

  15. Inflammatory markers in plasma

    IL-1β

    Measured: Fasting venous blood before the fourth administration

  16. Inflammatory markers in plasma

    IL-1β

    Measured: During the operation of total knee arthroplasty

  17. Inflammatory markers in plasma

    COX-2

    Measured: Fasting venous blood before the first administration

  18. Inflammatory markers in plasma

    COX-2

    Measured: 3 hours after the third administration

  19. Inflammatory markers in plasma

    COX-2

    Measured: 9 hours after the third administration

  20. Inflammatory markers in plasma

    COX-2

    Measured: Fasting venous blood before the fourth administration

  21. Inflammatory markers in plasma

    COX-2

    Measured: During the operation of total knee arthroplasty

  22. Inflammatory markers in plasma

    IL-6

    Measured: Fasting venous blood before the first administration

  23. Inflammatory markers in plasma

    IL-6

    Measured: 3 hours after the third administration

  24. Inflammatory markers in plasma

    IL-6

    Measured: 9 hours after the third administration

  25. Inflammatory markers in plasma

    IL-6

    Measured: Fasting venous blood before the fourth administration

  26. Inflammatory markers in plasma

    IL-6

    Measured: During the operation of total knee arthroplasty

  27. Inflammatory markers in plasma

    TNFα

    Measured: Fasting venous blood before the first administration

  28. Inflammatory markers in plasma

    TNFα

    Measured: 3 hours after the third administration

  29. Inflammatory markers in plasma

    TNFα

    Measured: 9 hours after the third administration

  30. Inflammatory markers in plasma

    TNFα

    Measured: Fasting venous blood before the fourth administration

  31. Inflammatory markers in plasma

    TNFα

    Measured: During the operation of total knee arthroplasty

  32. Inflammatory markers in plasma

    MMP-3

    Measured: Fasting venous blood before the first administration

  33. Inflammatory markers in plasma

    MMP-3

    Measured: 3 hours after the third administration

  34. Inflammatory markers in plasma

    MMP-3

    Measured: 9 hours after the third administration

  35. Inflammatory markers in plasma

    MMP-3

    Measured: Fasting venous blood before the fourth administration

  36. Inflammatory markers in plasma

    MMP-3

    Measured: During the operation of total knee arthroplasty

  37. Inflammatory markers in plasma

    ADAM-TS5

    Measured: Fasting venous blood before the first administration

  38. Inflammatory markers in plasma

    ADAM-TS5

    Measured: 3 hours after the third administration

  39. Inflammatory markers in plasma

    ADAM-TS5

    Measured: 9 hours after the third administration

  40. Inflammatory markers in plasma

    ADAM-TS5

    Measured: Fasting venous blood before the fourth administration

  41. Inflammatory markers in plasma

    ADAM-TS5

    Measured: During the operation of total knee arthroplasty

  42. Inflammatory markers in synovial fluid

    Leptin

    Measured: During the operation of total knee arthroplasty

  43. Inflammatory markers in synovial fluid

    IL-1β

    Measured: During the operation of total knee arthroplasty

  44. Inflammatory markers in synovial fluid

    COX-2

    Measured: During the operation of total knee arthroplasty

  45. Inflammatory markers in synovial fluid

    IL-6

    Measured: During the operation of total knee arthroplasty

  46. Inflammatory markers in synovial fluid

    TNFα

    Measured: During the operation of total knee arthroplasty

  47. Inflammatory markers in synovial fluid

    MMP-3

    Measured: During the operation of total knee arthroplasty

  48. Inflammatory markers in synovial fluid

    ADAM-TS5

    Measured: During the operation of total knee arthroplasty

  49. Gene polymorphism

    Gene polymorphisms of glucosamine transporters in vivo

    Measured: Fasting venous blood before the first administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start2 Jul 2017 (estimated)
  3. Primary completion1 Jul 2019 (estimated)
  4. Study completion1 Oct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03201276
Sponsor's protocol ID
glucosaminexzh
Status last verified
Jul 2017
First submitted
23 Jun 2017
Last updated
5 Jul 2017
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Chan PS, Caron JP, Orth MW. Effects of glucosamine and chondroitin sulfate on bovine cartilage explants under long-term culture conditions. Am J Vet Res. 2007 Jul;68(7):709-15. doi: 10.2460/ajvr.68.7.709.

    PubMed 17605605

  • Herrero-Beaumont G, Ivorra JA, Del Carmen Trabado M, Blanco FJ, Benito P, Martin-Mola E, Paulino J, Marenco JL, Porto A, Laffon A, Araujo D, Figueroa M, Branco J. Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator. Arthritis Rheum. 2007 Feb;56(2):555-67. doi: 10.1002/art.22371.

    PubMed 17265490

  • Setnikar I, Rovati LC. Absorption, distribution, metabolism and excretion of glucosamine sulfate. A review. Arzneimittelforschung. 2001 Sep;51(9):699-725. doi: 10.1055/s-0031-1300105.

    PubMed 11642003

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qing Jiang (+8613605192953, qingj@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug concentration in plasma (time frame: Fasting venous blood before the first administration). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03201276, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017; AzTrials last refreshed its copy on 28 Oct 2026.

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