- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01906281
Influence of Adipocytokines in Osteoarthritis
November 7, 2013 updated by: Joan Calvet Fontova, Hospital Parc Taulí, Sabadell
Adipocytokines Influence on Clinical and Ultrasonographic Inflammatory Activity in Patients With Knee Osteoarthritis
Adipocytokines play an important role in joint inflammation in patients with knee osteoarthritis as measured by ultrasound and high sensitivity protein-C reactive.
Adipocytokines could be the link between osteoarthritis and cardiovascular risk factors more prevalent in these patients.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Barcelona
-
Sabadell, Barcelona, Spain, 08208
- Recruiting
- Hospital Parc Tauli
-
Sabadell, Barcelona, Spain, 08208
- Recruiting
- Hospital Parc Tauli Sabadell
-
-
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
Ages Eligible for Study
50 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients over 50 years who were referred for rheumatology for symptomatic knee osteoarthritis.
Description
Inclusion Criteria:
- Patients over 50 years old with symptomatic knee osteoarthritis.
Exclusion Criteria:
- Patients with secondary osteoarthritis of the knee
- Any other rheumatologic condition.
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 |
Intervention / Treatment |
|---|---|
|
Inflammatory knee osteoarthritis
One group of patients with inflammatory condition in physical evaluation.
We will make a blood analyse and arthrocentesis when synovial fluid were found in ultrasound examination.
Ultrasound of affected knee and carotid artery will be performed.
|
|
|
Non-inflammatory knee osteoarthritis
Patients with no inflammatory condition in physical examination.
We will make a blood analyse and arthrocentesis when synovial fluid were found in ultrasound examination.
Ultrasound of affected knee and carotid artery will be performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
adipocytokine level
Time Frame: 18 months
|
We will determine the adipocytokine level at the end of inclusion period between 12-18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasound inflammatory exploration of the knee
Time Frame: 18 months
|
we evaluate the presence of synovial fluid with ultrasound evaluation in the visit of the patient.
Ultrasound evaluation will be performed by two Rheumatologists.
|
18 months
|
|
Ultrasound of carotid artery
Time Frame: 18 months
|
We will evaluate patients with ultrasound exploration in order to describe the presence of atheromatous disease in the visit of the patient
|
18 months
|
|
Cardiovascular risk factors
Time Frame: 18months
|
We evaluate the prevalence of cardiovascular risk factors in the symptomatic knee osteoarthritis patients, and the relationship with adipocytokines.
We will evaluate blood analyse levels of cholesterol, glycemia.
|
18months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: jordi Gratacos, MD Ph, Hospital Parc Tauli
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
July 1, 2013
Primary Completion (ANTICIPATED)
November 1, 2014
Study Completion (ANTICIPATED)
December 1, 2014
Study Registration Dates
First Submitted
July 5, 2013
First Submitted That Met QC Criteria
July 19, 2013
First Posted (ESTIMATE)
July 24, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
November 8, 2013
Last Update Submitted That Met QC Criteria
November 7, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Joan01
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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