Influence of Adipocytokines in Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Hospital Parc Taulí, Sabadell
Sponsor:
Information provided by (Responsible Party):
Joan Calvet Fontova, Hospital Parc Taulí, Sabadell
ClinicalTrials.gov Identifier:
NCT01906281
First received: July 5, 2013
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Endocrine System Diseases
Cardiovascular Risk Factors
Other: Blood analyse, arthrocentesis, ultrasound examination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adipocytokines Influence on Clinical and Ultrasonographic Inflammatory Activity in Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Hospital Parc Taulí, Sabadell:

Primary Outcome Measures:
  • adipocytokine level [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    We will determine the adipocytokine level at the end of inclusion period between 12-18 months


Secondary Outcome Measures:
  • Ultrasound inflammatory exploration of the knee [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    we evaluate the presence of synovial fluid with ultrasound evaluation in the visit of the patient. Ultrasound evaluation will be performed by two Rheumatologists.

  • Ultrasound of carotid artery [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    We will evaluate patients with ultrasound exploration in order to describe the presence of atheromatous disease in the visit of the patient

  • Cardiovascular risk factors [ Time Frame: 18months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

First we analyze the blood and articular fluid adipocytokines. If we can define a subset of patients characterized by a pattern of adipocytokines, genetic analysis will be performed later.


Estimated Enrollment: 105
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
Other: Blood analyse, arthrocentesis, ultrasound examination

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients over 50 years who were referred for rheumatology for symptomatic knee osteoarthritis.

Criteria

Inclusion Criteria:

  • Patients over 50 years old with symptomatic knee osteoarthritis.

Exclusion Criteria:

  • Patients with secondary osteoarthritis of the knee
  • Any other rheumatologic condition.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906281

Contacts
Contact: Joan Calvet, Dr 0034 937231010 ext 24065 joan.calvet.fontova@gmail.com
Contact: Cristobal Orellana, Dr 0034 937231010 ext 24059 cristobalorellana1@gmail.com

Locations
Spain
Hospital Parc Tauli Sabadell Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Joan Calvet, Dr    0034937231010 ext 24065    joan.calvet.fontova@gmail.com   
Principal Investigator: Joan Calvet, Dr         
Sub-Investigator: Cristobal Orellana, Dr         
Sub-Investigator: Maria Garcia-Manrique, Dra         
Hospital Parc Tauli Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Joan Calvet, Dr    0034937231010 ext 24065    joan.calvet.fontova@gmail.com   
Contact: Cristobal Orellana, Dr    0034937231010 ext 24065    corellana@tauli.cat   
Principal Investigator: Joan Calvet, Dr         
Sub-Investigator: Cristobal Orellana, Dr         
Sub-Investigator: Maria Garcia-Manrique, Dra         
Sponsors and Collaborators
Hospital Parc Taulí, Sabadell
Investigators
Study Director: jordi Gratacos, MD Ph Hospital Parc Tauli
  More Information

No publications provided

Responsible Party: Joan Calvet Fontova, Dr, Hospital Parc Taulí, Sabadell
ClinicalTrials.gov Identifier: NCT01906281     History of Changes
Other Study ID Numbers: Joan01
Study First Received: July 5, 2013
Last Updated: November 7, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Parc Taulí, Sabadell:
adipocytokines
osteoarthritis
cardiovascular risk

Additional relevant MeSH terms:
Endocrine System Diseases
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 21, 2014