Individual Differences in Glucosamine Sulfate Exposure Levels

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Glucosamine Sulfate

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Ruijuan Xu; Phone Number: +8613851502360; Email: jean0129@163.com
• Study Contact Backup: Name: Qing Jiang; Phone Number: +8613605192953; Email: qingj@nju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing total knee arthroplasty for knee osteoarthritis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Drug group; patients taking glucosamine	Drug: Glucosamine Sulfate; Patients taking glucosamine sulfate 1500mg every day for at least four days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 2, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: gene polymorphism; glucosamine sulfate; individual differences
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: glucosaminexzh

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No