Individual Differences in Glucosamine Sulfate Exposure Levels

NCT03201276 — Unknown, 400 participants, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Registry	NCT03201276
Status	Unknown
Study type	Observational
Enrollment	400 (Estimated)
Sponsor	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Conditions	Knee Osteoarthritis
Interventions	Glucosamine Sulfate (Drug)
Dates	start 2017-07-02 (estimated), primary completion 2019-07-01 (estimated), completion 2019-10-01 (estimated), first posted 2017-06-28, last updated 2017-07-05

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Drug group		Drug: Glucosamine Sulfate	patients taking glucosamine

Glucosamine Sulfate (Drug): Patients taking glucosamine sulfate 1500mg every day for at least four days.

+Outcome measures

Primary outcomes

Drug concentration in plasma [Fasting venous blood before the first administration]: Drug concentration is measured by HPLC-MS/MS
Drug concentration in plasma [3 hours after the third administration]: Drug concentration is measured by HPLC-MS/MS
Drug concentration in plasma [9 hours after the third administration]: Drug concentration is measured by HPLC-MS/MS
Drug concentration in plasma [Fasting venous blood before the fourth administration]: Drug concentration is measured by HPLC-MS/MS
Drug concentration in plasma [Venous blood during the operation of total knee arthroplasty]: Drug concentration is measured by HPLC-MS/MS
Drug concentration in synovial fluid [During the operation of total knee arthroplasty]: Drug concentration is measured by HPLC-MS/MS
Inflammatory markers in plasma [Fasting venous blood before the first administration]: Leptin
Inflammatory markers in plasma [3 hours after the third administration]: Leptin
Inflammatory markers in plasma [9 hours after the third administration]: Leptin
Inflammatory markers in plasma [Fasting venous blood before the fourth administration]: Leptin
Inflammatory markers in plasma [During the operation of total knee arthroplasty]: Leptin
Inflammatory markers in plasma [Fasting venous blood before the first administration]: IL-1β
Inflammatory markers in plasma [3 hours after the third administration]: IL-1β
Inflammatory markers in plasma [9 hours after the third administration]: IL-1β
Inflammatory markers in plasma [Fasting venous blood before the fourth administration]: IL-1β
Inflammatory markers in plasma [During the operation of total knee arthroplasty]: IL-1β
Inflammatory markers in plasma [Fasting venous blood before the first administration]: COX-2
Inflammatory markers in plasma [3 hours after the third administration]: COX-2
Inflammatory markers in plasma [9 hours after the third administration]: COX-2
Inflammatory markers in plasma [Fasting venous blood before the fourth administration]: COX-2
Inflammatory markers in plasma [During the operation of total knee arthroplasty]: COX-2
Inflammatory markers in plasma [Fasting venous blood before the first administration]: IL-6
Inflammatory markers in plasma [3 hours after the third administration]: IL-6
Inflammatory markers in plasma [9 hours after the third administration]: IL-6
Inflammatory markers in plasma [Fasting venous blood before the fourth administration]: IL-6
Inflammatory markers in plasma [During the operation of total knee arthroplasty]: IL-6
Inflammatory markers in plasma [Fasting venous blood before the first administration]: TNFα
Inflammatory markers in plasma [3 hours after the third administration]: TNFα
Inflammatory markers in plasma [9 hours after the third administration]: TNFα
Inflammatory markers in plasma [Fasting venous blood before the fourth administration]: TNFα
Inflammatory markers in plasma [During the operation of total knee arthroplasty]: TNFα
Inflammatory markers in plasma [Fasting venous blood before the first administration]: MMP-3
Inflammatory markers in plasma [3 hours after the third administration]: MMP-3
Inflammatory markers in plasma [9 hours after the third administration]: MMP-3
Inflammatory markers in plasma [Fasting venous blood before the fourth administration]: MMP-3
Inflammatory markers in plasma [During the operation of total knee arthroplasty]: MMP-3
Inflammatory markers in plasma [Fasting venous blood before the first administration]: ADAM-TS5
Inflammatory markers in plasma [3 hours after the third administration]: ADAM-TS5
Inflammatory markers in plasma [9 hours after the third administration]: ADAM-TS5
Inflammatory markers in plasma [Fasting venous blood before the fourth administration]: ADAM-TS5
Inflammatory markers in plasma [During the operation of total knee arthroplasty]: ADAM-TS5
Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]: Leptin
Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]: IL-1β
Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]: COX-2
Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]: IL-6
Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]: TNFα
Inflammatory markers in synovial fluid [During the operation of total knee arthroplasty]: MMP-3
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

+Eligibility

Sex: All, ages: 60 Years to 80 Years

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.

+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. PMID 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. PMID 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. PMID 11642003

My Notes

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