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Obesity and the Initiation of Knee Osteoarthritis

Obesity and Initiation of Osteoarthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00856739
Enrollment
177
Registered
2009-03-06
Start date
2009-03-31
Completion date
2012-03-31
Last updated
2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, arthritis

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.

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.

Interventions

None listed

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Observational model
ECOLOGIC_OR_COMMUNITY

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gait Knee Adduction Momentbaseline or first and only visit.
Cartilage Thicknessbaseline or first and only visit.Medial/lateral thickness ratio

Countries

United States

Participant flow

Participants by arm

ArmCount
Normal Weight
Body mass index between 18 and 25 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
70
Overweight
Body mass index between 25 and 30 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
52
Obese
Body mass index between 30 and 50 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
55
Total177

Baseline characteristics

CharacteristicNormal WeightOverweightObeseTotal
Age, Continuous39.2 years
STANDARD_DEVIATION 11.99
40.91 years
STANDARD_DEVIATION 13.08
39.8 years
STANDARD_DEVIATION 11.27
39.89 years
STANDARD_DEVIATION 12.06
Sex: Female, Male
Female
40 Participants16 Participants34 Participants90 Participants
Sex: Female, Male
Male
30 Participants36 Participants21 Participants87 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

Cartilage Thickness

Medial/lateral thickness ratio

Time frame: baseline or first and only visit.

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Normal WeightCartilage Thickness1.069 mm/mmStandard Deviation 0.097
ObeseCartilage Thickness1.04571 mm/mmStandard Deviation 0.169
Normal Weight Middle AgeCartilage Thickness1.051 mm/mmStandard Deviation 0.127
Overweight and Obese Middle AgeCartilage Thickness1.069 mm/mmStandard Deviation 0.139
Primary

Gait Knee Adduction Moment

Time frame: baseline or first and only visit.

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Normal WeightGait Knee Adduction Moment3.14 percent body weight (N)*height (m)Standard Deviation 0.816
ObeseGait Knee Adduction Moment2.39 percent body weight (N)*height (m)Standard Deviation 0.765

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026