Individual Differences in Glucosamine Sulfate Exposure Levels

July 3, 2017 updated by: Qing Jiang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Drug concentration in plasma
Time Frame: Fasting venous blood before the first administration
Drug concentration is measured by HPLC-MS/MS
Fasting venous blood before the first administration
Drug concentration in plasma
Time Frame: 3 hours after the third administration
Drug concentration is measured by HPLC-MS/MS
3 hours after the third administration
Drug concentration in plasma
Time Frame: 9 hours after the third administration
Drug concentration is measured by HPLC-MS/MS
9 hours after the third administration
Drug concentration in plasma
Time Frame: Fasting venous blood before the fourth administration
Drug concentration is measured by HPLC-MS/MS
Fasting venous blood before the fourth administration
Drug concentration in plasma
Time Frame: Venous blood during the operation of total knee arthroplasty
Drug concentration is measured by HPLC-MS/MS
Venous blood during the operation of total knee arthroplasty
Drug concentration in synovial fluid
Time Frame: During the operation of total knee arthroplasty
Drug concentration is measured by HPLC-MS/MS
During the operation of total knee arthroplasty
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the first administration
Leptin
Fasting venous blood before the first administration
Inflammatory markers in plasma
Time Frame: 3 hours after the third administration
Leptin
3 hours after the third administration
Inflammatory markers in plasma
Time Frame: 9 hours after the third administration
Leptin
9 hours after the third administration
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the fourth administration
Leptin
Fasting venous blood before the fourth administration
Inflammatory markers in plasma
Time Frame: During the operation of total knee arthroplasty
Leptin
During the operation of total knee arthroplasty
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the first administration
IL-1β
Fasting venous blood before the first administration
Inflammatory markers in plasma
Time Frame: 3 hours after the third administration
IL-1β
3 hours after the third administration
Inflammatory markers in plasma
Time Frame: 9 hours after the third administration
IL-1β
9 hours after the third administration
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the fourth administration
IL-1β
Fasting venous blood before the fourth administration
Inflammatory markers in plasma
Time Frame: During the operation of total knee arthroplasty
IL-1β
During the operation of total knee arthroplasty
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the first administration
COX-2
Fasting venous blood before the first administration
Inflammatory markers in plasma
Time Frame: 3 hours after the third administration
COX-2
3 hours after the third administration
Inflammatory markers in plasma
Time Frame: 9 hours after the third administration
COX-2
9 hours after the third administration
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the fourth administration
COX-2
Fasting venous blood before the fourth administration
Inflammatory markers in plasma
Time Frame: During the operation of total knee arthroplasty
COX-2
During the operation of total knee arthroplasty
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the first administration
IL-6
Fasting venous blood before the first administration
Inflammatory markers in plasma
Time Frame: 3 hours after the third administration
IL-6
3 hours after the third administration
Inflammatory markers in plasma
Time Frame: 9 hours after the third administration
IL-6
9 hours after the third administration
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the fourth administration
IL-6
Fasting venous blood before the fourth administration
Inflammatory markers in plasma
Time Frame: During the operation of total knee arthroplasty
IL-6
During the operation of total knee arthroplasty
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the first administration
TNFα
Fasting venous blood before the first administration
Inflammatory markers in plasma
Time Frame: 3 hours after the third administration
TNFα
3 hours after the third administration
Inflammatory markers in plasma
Time Frame: 9 hours after the third administration
TNFα
9 hours after the third administration
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the fourth administration
TNFα
Fasting venous blood before the fourth administration
Inflammatory markers in plasma
Time Frame: During the operation of total knee arthroplasty
TNFα
During the operation of total knee arthroplasty
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the first administration
MMP-3
Fasting venous blood before the first administration
Inflammatory markers in plasma
Time Frame: 3 hours after the third administration
MMP-3
3 hours after the third administration
Inflammatory markers in plasma
Time Frame: 9 hours after the third administration
MMP-3
9 hours after the third administration
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the fourth administration
MMP-3
Fasting venous blood before the fourth administration
Inflammatory markers in plasma
Time Frame: During the operation of total knee arthroplasty
MMP-3
During the operation of total knee arthroplasty
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the first administration
ADAM-TS5
Fasting venous blood before the first administration
Inflammatory markers in plasma
Time Frame: 3 hours after the third administration
ADAM-TS5
3 hours after the third administration
Inflammatory markers in plasma
Time Frame: 9 hours after the third administration
ADAM-TS5
9 hours after the third administration
Inflammatory markers in plasma
Time Frame: Fasting venous blood before the fourth administration
ADAM-TS5
Fasting venous blood before the fourth administration
Inflammatory markers in plasma
Time Frame: During the operation of total knee arthroplasty
ADAM-TS5
During the operation of total knee arthroplasty
Inflammatory markers in synovial fluid
Time Frame: During the operation of total knee arthroplasty
Leptin
During the operation of total knee arthroplasty
Inflammatory markers in synovial fluid
Time Frame: During the operation of total knee arthroplasty
IL-1β
During the operation of total knee arthroplasty
Inflammatory markers in synovial fluid
Time Frame: During the operation of total knee arthroplasty
COX-2
During the operation of total knee arthroplasty
Inflammatory markers in synovial fluid
Time Frame: During the operation of total knee arthroplasty
IL-6
During the operation of total knee arthroplasty
Inflammatory markers in synovial fluid
Time Frame: During the operation of total knee arthroplasty
TNFα
During the operation of total knee arthroplasty
Inflammatory markers in synovial fluid
Time Frame: During the operation of total knee arthroplasty
MMP-3
During the operation of total knee arthroplasty
Inflammatory markers in synovial fluid
Time Frame: During the operation of total knee arthroplasty
ADAM-TS5
During the operation of total knee arthroplasty
Gene polymorphism
Time Frame: Fasting venous blood before the first administration
Gene polymorphisms of glucosamine transporters in vivo
Fasting venous blood before the first administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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