Individual Differences in Glucosamine Sulfate Exposure Levels

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03201276
• Other study ID #: glucosaminexzh
• Status: Not yet recruiting
• Phase: N/A
• First received: June 23, 2017
• Last updated: July 3, 2017
• Start date: July 2, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2017
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Qing Jiang
• Phone: +8613605192953
• Email: qingj[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: October 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

References & 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. — View Citation

Herrero-Beaumont G, Ivorra JA, Del Carmen Trabado M, Blanco FJ, Benito P, Martín-Mola E, Paulino J, Marenco JL, Porto A, Laffon A, Araújo 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. — View Citation

Setnikar I, Rovati LC. Absorption, distribution, metabolism and excretion of glucosamine sulfate. A review. Arzneimittelforschung. 2001 Sep;51(9):699-725. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug concentration in plasma	Drug concentration is measured by HPLC-MS/MS	Fasting venous blood before the first administration
Primary	Drug concentration in plasma	Drug concentration is measured by HPLC-MS/MS	3 hours after the third administration
Primary	Drug concentration in plasma	Drug concentration is measured by HPLC-MS/MS	9 hours after the third administration
Primary	Drug concentration in plasma	Drug concentration is measured by HPLC-MS/MS	Fasting venous blood before the fourth administration
Primary	Drug concentration in plasma	Drug concentration is measured by HPLC-MS/MS	Venous blood during the operation of total knee arthroplasty
Primary	Drug concentration in synovial fluid	Drug concentration is measured by HPLC-MS/MS	During the operation of total knee arthroplasty
Primary	Inflammatory markers in plasma	Leptin	Fasting venous blood before the first administration
Primary	Inflammatory markers in plasma	Leptin	3 hours after the third administration
Primary	Inflammatory markers in plasma	Leptin	9 hours after the third administration
Primary	Inflammatory markers in plasma	Leptin	Fasting venous blood before the fourth administration
Primary	Inflammatory markers in plasma	Leptin	During the operation of total knee arthroplasty
Primary	Inflammatory markers in plasma	IL-1ß	Fasting venous blood before the first administration
Primary	Inflammatory markers in plasma	IL-1ß	3 hours after the third administration
Primary	Inflammatory markers in plasma	IL-1ß	9 hours after the third administration
Primary	Inflammatory markers in plasma	IL-1ß	Fasting venous blood before the fourth administration
Primary	Inflammatory markers in plasma	IL-1ß	During the operation of total knee arthroplasty
Primary	Inflammatory markers in plasma	COX-2	Fasting venous blood before the first administration
Primary	Inflammatory markers in plasma	COX-2	3 hours after the third administration
Primary	Inflammatory markers in plasma	COX-2	9 hours after the third administration
Primary	Inflammatory markers in plasma	COX-2	Fasting venous blood before the fourth administration
Primary	Inflammatory markers in plasma	COX-2	During the operation of total knee arthroplasty
Primary	Inflammatory markers in plasma	IL-6	Fasting venous blood before the first administration
Primary	Inflammatory markers in plasma	IL-6	3 hours after the third administration
Primary	Inflammatory markers in plasma	IL-6	9 hours after the third administration
Primary	Inflammatory markers in plasma	IL-6	Fasting venous blood before the fourth administration
Primary	Inflammatory markers in plasma	IL-6	During the operation of total knee arthroplasty
Primary	Inflammatory markers in plasma	TNFa	Fasting venous blood before the first administration
Primary	Inflammatory markers in plasma	TNFa	3 hours after the third administration
Primary	Inflammatory markers in plasma	TNFa	9 hours after the third administration
Primary	Inflammatory markers in plasma	TNFa	Fasting venous blood before the fourth administration
Primary	Inflammatory markers in plasma	TNFa	During the operation of total knee arthroplasty
Primary	Inflammatory markers in plasma	MMP-3	Fasting venous blood before the first administration
Primary	Inflammatory markers in plasma	MMP-3	3 hours after the third administration
Primary	Inflammatory markers in plasma	MMP-3	9 hours after the third administration
Primary	Inflammatory markers in plasma	MMP-3	Fasting venous blood before the fourth administration
Primary	Inflammatory markers in plasma	MMP-3	During the operation of total knee arthroplasty
Primary	Inflammatory markers in plasma	ADAM-TS5	Fasting venous blood before the first administration
Primary	Inflammatory markers in plasma	ADAM-TS5	3 hours after the third administration
Primary	Inflammatory markers in plasma	ADAM-TS5	9 hours after the third administration
Primary	Inflammatory markers in plasma	ADAM-TS5	Fasting venous blood before the fourth administration
Primary	Inflammatory markers in plasma	ADAM-TS5	During the operation of total knee arthroplasty
Primary	Inflammatory markers in synovial fluid	Leptin	During the operation of total knee arthroplasty
Primary	Inflammatory markers in synovial fluid	IL-1ß	During the operation of total knee arthroplasty
Primary	Inflammatory markers in synovial fluid	COX-2	During the operation of total knee arthroplasty
Primary	Inflammatory markers in synovial fluid	IL-6	During the operation of total knee arthroplasty
Primary	Inflammatory markers in synovial fluid	TNFa	During the operation of total knee arthroplasty
Primary	Inflammatory markers in synovial fluid	MMP-3	During the operation of total knee arthroplasty
Primary	Inflammatory markers in synovial fluid	ADAM-TS5	During the operation of total knee arthroplasty
Primary	Gene polymorphism	Gene polymorphisms of glucosamine transporters in vivo	Fasting venous blood before the first administration