NCT03201276

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

July 2, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 5, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

June 23, 2017

Last Update Submit

July 3, 2017

Conditions

Knee Osteoarthritis

Keywords

glucosamine sulfateindividual differencesgene polymorphism

Outcome Measures

Primary Outcomes (49)

  • 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

Study Arms (1)

Drug group

patients taking glucosamine

Drug: Glucosamine Sulfate

Interventions

Glucosamine SulfateDRUG

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

Drug group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing total knee arthroplasty for knee osteoarthritis

You may qualify if:

  • patients undergoing total knee arthroplasty for knee osteoarthritis;
  • years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 17605605BACKGROUND

  • 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.

    PMID: 17265490BACKGROUND

  • 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.

    PMID: 11642003BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucosamine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HexosaminesAmino SugarsCarbohydrates

Central Study Contacts

Qing Jiang

CONTACT

+8613605192953qingj@nju.edu.cn

Ruijuan Xu

CONTACT

+8613851502360jean0129@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Dean

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 28, 2017

Study Start

July 2, 2017

Primary Completion

July 1, 2019

Study Completion

October 1, 2019

Last Updated

July 5, 2017

Record last verified: 2017-07