ObesityNCT00856739

Obesity and the Initiation of Knee Osteoarthritis

An observational study of Obesity, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
How many people: 177 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Mar 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 60 years
All sexes
Healthy volunteers accepted
Adult

Study population: Healthy adults aged 20-60, of varying weights.

Who may be able to join

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

Who cannot join

Adults who have had LE surgery
Adults cannot walk 30 minutes
Adults who cannot tolerate MR
Adults with osteoarthritis

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Palo Alto Health Care System
Palo Alto, California, 94304-1290

Other trials in United States

About this study

Official title: Obesity and Initiation of Osteoarthritis

Read the 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.

Conditions: Obesity
Keywords: obesity, arthritis
Medical subject headings: Obesity, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00856739
Study group	Role	What they receive
Group 1		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Gait Knee Adduction Moment
Measured: baseline or first and only visit.
Cartilage Thickness
Medial/lateral thickness ratio
Measured: baseline or first and only visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Mar 2012

First posted6 Mar 2009 (estimated)
Study startMar 2009
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ObesityStudies 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: Ecologic or community
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00856739
Sponsor's protocol ID: A6650-R
Other IDs: 7924
Status last verified: Dec 2014
First submitted: 5 Mar 2009
Last updated: 19 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Blazek K, Favre J, Asay J, Erhart-Hledik J, Andriacchi T. Age and obesity alter the relationship between femoral articular cartilage thickness and ambulatory loads in individuals without osteoarthritis. J Orthop Res. 2014 Mar;32(3):394-402. doi: 10.1002/jor.22530. Epub 2013 Nov 26.
PubMed 24281940
Blazek K, Asay JL, Erhart-Hledik J, Andriacchi T. Adduction moment increases with age in healthy obese individuals. J Orthop Res. 2013 Sep;31(9):1414-22. doi: 10.1002/jor.22390. Epub 2013 Jun 4.
PubMed 23737249

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Obesity and Initiation of Osteoarthritis
ClinicalTrials.gov ID: NCT00856739
Acronym / sponsor ID: A6650-R
Conditions: Obesity
Keywords: obesity, arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Mar 2009
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 6 Mar 2009 (estimated)
Results: Posted 19 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Ecologic or community
Number of arms: 1

Arm	Type	Receives
Group 1	–	–

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: Healthy adults aged 20-60, of varying weights.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

Adults who have had LE surgery
Adults cannot walk 30 minutes
Adults who cannot tolerate MR
Adults with osteoarthritis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Gait Knee Adduction Moment
Time frame: baseline or first and only visit.
Cartilage Thickness
Time frame: baseline or first and only visit.
Medial/lateral thickness ratio

Results and safety

Results posted to the registry on 19 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Weight	70	70
Overweight	52	52
Obese	55	55

Primary outcome: Gait Knee Adduction Moment

Time frame: baseline or first and only visit.. Mean (Standard Deviation). Unit: percent body weight (N)*height (m)

Measure	Normal Weight n = 59	Obese n = 36
Value	3.14 (0.816)	2.39 (0.765)

Population analysed: Obese were compared to healthy weight subjects. No overweight subjects were used in this analysis. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.

Primary outcome: Cartilage Thickness

Time frame: baseline or first and only visit.. Mean (Standard Deviation). Unit: mm/mm

Measure	Normal Weight Young n = 28	Overweight and Obese Young n = 28	Normal Weight Middle Age n = 27	Overweight and Obese Middle Age n = 27
Value	1.069 (0.097)	1.04571 (0.169)	1.051 (0.127)	1.069 (0.139)

Population analysed: Overweight and obese were combined based on similarities found in literature. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Weight	0 of 0	0 of 0	Not reported
Overweight	0 of 0	0 of 0	Not reported
Obese	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24281940Blazek K, Favre J, Asay J, Erhart-Hledik J, Andriacchi T. Age and obesity alter the relationship between femoral articular cartilage thickness and ambulatory loads in individuals without osteoarthritis. J Orthop Res. 2014 Mar;32(3):394-402. doi: 10.1002/jor.22530. Epub 2013 Nov 26.
Results publication: PubMed 23737249Blazek K, Asay JL, Erhart-Hledik J, Andriacchi T. Adduction moment increases with age in healthy obese individuals. J Orthop Res. 2013 Sep;31(9):1414-22. doi: 10.1002/jor.22390. Epub 2013 Jun 4.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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.

Thomas P. Andriacchi, PhD principal investigator

VA Palo Alto Health Care System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by US Department of Veterans Affairs at 1 site in United States.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 19 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Knee Adduction Moment (time frame: baseline or first and only visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00856739, which also lists 2 linked publications.

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 19 Dec 2014.