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Obesity and the Initiation of Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00856739
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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Brief Summary:
Healthy adults aged 20-60 of varying weights will participate in this minimally invasive study. There is one 4-hour appointment for which subjects are paid $120. The tests involve: 1 tube blood draw, 1 gait test (motion capture) and 1 MR of both knees.

Condition or disease
Obesity

Detailed Description:
The tests will be done at the VA and Stanford and are not dangerous or painful. They are designed to help us learn more about the relationship of excess weight on cartilage degradation by testing a biomarker in blood. Gait testing involves walking in a lab that is about 20 meters long about 20 times. MR involves lying in a tube for less than 1 hour.
Study Design
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Study Type : Observational
Actual Enrollment : 177 participants
Observational Model: Ecologic or Community
Official Title: Obesity and Initiation of Osteoarthritis
Study Start Date : March 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Groups and Cohorts
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Group/Cohort
Group 1


Outcome Measures
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Primary Outcome Measures :
  1. Gait Knee Adduction Moment [ Time Frame: baseline or first and only visit. ]
  2. Cartilage Thickness [ Time Frame: baseline or first and only visit. ]
    Medial/lateral thickness ratio


Biospecimen Retention:   Samples Without DNA
One tube of blood identified with a unique number.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults aged 20-60, of varying weights.
Criteria

Inclusion Criteria:

  • Healthy Adults aged 20-60 who have no history of LE surgery
  • Healthy adults able to walk 30 minutes
  • Healthy adults able to have MR

Exclusion Criteria:

  • Adults who have had LE surgery
  • Adults cannot walk 30 minutes
  • Adults who cannot tolerate MR
  • Adults with osteoarthritis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856739


Locations
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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Thomas P. Andriacchi, PhD VA Palo Alto Health Care System
More Information
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Publications of Results:

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00856739    
Other Study ID Numbers: A6650-R
7924 ( Other Identifier: IRB protocol number )
First Posted: March 6, 2009    Key Record Dates
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
obesity
arthritis
Additional relevant MeSH terms:
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Osteoarthritis
Obesity
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases