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Obesity and the Initiation of Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00856739
First received: March 5, 2009
Last updated: December 10, 2014
Last verified: December 2014
  Purpose
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
Obesity

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Official Title: Obesity and Initiation of Osteoarthritis

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Gait Knee Adduction Moment [ Time Frame: baseline or first and only visit. ] [ Designated as safety issue: No ]
  • Cartilage Thickness [ Time Frame: baseline or first and only visit. ] [ Designated as safety issue: No ]
    Medial/lateral thickness ratio


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

Enrollment: 177
Study Start Date: March 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

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.
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
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: NCT00856739

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Thomas P. Andriacchi, PhD VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00856739     History of Changes
Other Study ID Numbers: A6650-R  7924 
Study First Received: March 5, 2009
Results First Received: December 2, 2014
Last Updated: December 10, 2014
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
obesity
arthritis

Additional relevant MeSH terms:
Obesity
Osteoarthritis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 30, 2016