Obesity and the Initiation of Knee Osteoarthritis

This study is currently recruiting participants.

Verified October 2011 by Department of Veterans Affairs

First Received on March 5, 2009. Last Updated on October 19, 2011 History of Changes

Sponsor:	Department of Veterans Affairs
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00856739

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:

MedlinePlus related topics: Obesity Osteoarthritis

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Knee MR cartilage wear, Gait knee adduction moment, COMP value in blood. [ Time Frame: baseline or first and only visit. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

One tube of blood identified with a unique number.

Estimated Enrollment:	200
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856739

Contacts

Contact: Jessica L Asay		asay@va51.stanford.edu
Contact: Jennifer Erhart, PhD	(650) 723-5793	Jennifer.Erhart@va.gov

Locations

United States, California
VA Palo Alto Health Care System	Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Jessica L Asay asay@va51.stanford.edu
Contact: Jennifer Erhart, PhD (650) 723-5793 Jennifer.Erhart@va.gov
Principal Investigator: Thomas P. Andriacchi, PhD
Sub-Investigator: Barbara Elspas
Sub-Investigator: Jessica L. Asay
Sub-Investigator: Jennifer Erhart, PhD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Thomas P. Andriacchi, PhD

VA Palo Alto Health Care System

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00856739 History of Changes
Other Study ID Numbers:	A6650R, 7924
Study First Received:	March 5, 2009
Last Updated:	October 19, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

obesity
arthritis

Additional relevant MeSH terms:

Obesity
Osteoarthritis
Osteoarthritis, Knee
Overnutrition
Nutrition Disorders
Overweight

Body Weight
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012