Clinical trial NCT03201276: Individual Differences in Glucosamine Sulfate Exposure Levels
Official title: Individual Differences in Glucosamine Sulfate Exposure Levels and Related Gene Polymorphism Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Keywords: glucosamine sulfate
individual differences
gene polymorphism
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing total knee arthroplasty for knee osteoarthritis

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Drug concentration in plasma
timeFrame: Fasting venous blood before the first administration
measure: Drug concentration in plasma
timeFrame: 3 hours after the third administration
measure: Drug concentration in plasma
timeFrame: 9 hours after the third administration
measure: Drug concentration in plasma
timeFrame: Fasting venous blood before the fourth administration
measure: Drug concentration in plasma
timeFrame: Venous blood during the operation of total knee arthroplasty
measure: Drug concentration in synovial fluid
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the first administration
measure: Inflammatory markers in plasma
timeFrame: 3 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: 9 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the fourth administration
measure: Inflammatory markers in plasma
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the first administration
measure: Inflammatory markers in plasma
timeFrame: 3 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: 9 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the fourth administration
measure: Inflammatory markers in plasma
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the first administration
measure: Inflammatory markers in plasma
timeFrame: 3 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: 9 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the fourth administration
measure: Inflammatory markers in plasma
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the first administration
measure: Inflammatory markers in plasma
timeFrame: 3 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: 9 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the fourth administration
measure: Inflammatory markers in plasma
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the first administration
measure: Inflammatory markers in plasma
timeFrame: 3 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: 9 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the fourth administration
measure: Inflammatory markers in plasma
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the first administration
measure: Inflammatory markers in plasma
timeFrame: 3 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: 9 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the fourth administration
measure: Inflammatory markers in plasma
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the first administration
measure: Inflammatory markers in plasma
timeFrame: 3 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: 9 hours after the third administration
measure: Inflammatory markers in plasma
timeFrame: Fasting venous blood before the fourth administration
measure: Inflammatory markers in plasma
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in synovial fluid
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in synovial fluid
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in synovial fluid
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in synovial fluid
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in synovial fluid
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in synovial fluid
timeFrame: During the operation of total knee arthroplasty
measure: Inflammatory markers in synovial fluid
timeFrame: During the operation of total knee arthroplasty
measure: Gene polymorphism
timeFrame: Fasting venous blood before the first administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.