Osteoarthritis, KneeNCT01906281
Influence of Adipocytokines in Osteoarthritis
An observational study of Osteoarthritis, Knee and Endocrine System Diseases, run by Parc Taulí Hospital Universitari at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Endocrine System Diseases, Cardiovascular Risk Factors
- What is being tested?
- Blood analyse, arthrocentesis, ultrasound examination
- How many people
- 105 participants
- Where
- 2 sitesSpain
- Study dates
- Jul 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients over 50 years who were referred for rheumatology for symptomatic knee osteoarthritis.
Who may be able to join
- Patients over 50 years old with symptomatic knee osteoarthritis.
Who cannot join
- Patients with secondary osteoarthritis of the knee
- Any other rheumatologic condition.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Parc Tauli Sabadell
Sabadell, Barcelona, 08208
Joan Calvet, Dr, 0034937231010 ext. 24065, joan.calvet.fontova@gmail.com
Joan Calvet, Dr
- Recruiting
Hospital Parc Tauli
Sabadell, Barcelona, 08208
Joan Calvet, Dr, 0034937231010 ext. 24065, joan.calvet.fontova@gmail.com
Cristobal Orellana, Dr, 0034937231010 ext. 24065, corellana@tauli.cat
About this study
Official title: 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.
- Being tested
- Blood analyse, arthrocentesis, ultrasound examination
- Keywords
- adipocytokines, osteoarthritis, cardiovascular risk
- Medical subject headings
- Osteoarthritis, Knee, Endocrine System Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood analyse, arthrocentesis, ultrasound examinationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood analyse, arthrocentesis, ultrasound examination | |
| 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. Receives: Other: Blood analyse, arthrocentesis, ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
adipocytokine level
We will determine the adipocytokine level at the end of inclusion period between 12-18 months
Measured: 18 months
Secondary outcomes (3)
Ultrasound inflammatory exploration of the knee
we evaluate the presence of synovial fluid with ultrasound evaluation in the visit of the patient. Ultrasound evaluation will be performed by two Rheumatologists.
Measured: 18 months
Ultrasound of carotid artery
We will evaluate patients with ultrasound exploration in order to describe the presence of atheromatous disease in the visit of the patient
Measured: 18 months
Cardiovascular risk factors
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.
Measured: 18months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Calvet Fontova, Parc Taulí Hospital Universitari
- Investigators
- jordi Gratacos, MD Ph, Study director, Hospital Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906281
- Sponsor's protocol ID
- Joan01
- Status last verified
- Nov 2013
- First submitted
- 5 Jul 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipocytokines Influence on Clinical and Ultrasonographic Inflammatory Activity in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01906281
- Acronym / sponsor ID
- Joan01
- Keywords
- adipocytokines, osteoarthritis, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory knee osteoarthritis | – | Other: Blood analyse, arthrocentesis, ultrasound examinationOne 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 | – | Other: Blood analyse, arthrocentesis, ultrasound examinationPatients 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients over 50 years who were referred for rheumatology for symptomatic knee osteoarthritis.
Key inclusion criteria (1 listed)
- Patients over 50 years old with symptomatic knee osteoarthritis.
Key exclusion criteria (2 listed)
- Patients with secondary osteoarthritis of the knee
- Any other rheumatologic condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood analyse, arthrocentesis, ultrasound examination | Other | Inflammatory knee osteoarthritis, Non-inflammatory knee osteoarthritis |
Primary outcome
adipocytokine level
Time frame: 18 months
We will determine the adipocytokine level at the end of inclusion period between 12-18 months
3 secondary outcomes
Ultrasound inflammatory exploration of the knee
Time frame: 18 months
Ultrasound of carotid artery
Time frame: 18 months
Cardiovascular risk factors
Time frame: 18months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jordi Gratacos, MD Ph study director
Hospital Parc Tauli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Endocrine System Diseases, run by Parc Taulí Hospital Universitari at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joan Calvet, Dr (0034 937231010 ext. 24065, joan.calvet.fontova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adipocytokine level (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.