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| ID | Type | Description | Link |
|---|---|---|---|
| 7924 | Other Identifier | IRB protocol number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Gait Knee Adduction Moment | baseline or first and only visit. | |
| Cartilage Thickness | Medial/lateral thickness ratio | baseline or first and only visit. |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy adults aged 20-60, of varying weights.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas P. Andriacchi, PhD | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1290 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24281940 | Result | 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. | |
| 23737249 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Weight | Body mass index between 18 and 25 kg/m^2 |
| FG001 | Overweight | Body mass index between 25 and 30 kg/m^2 |
| FG002 | Obese | Body mass index over 30 kg/m^2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Overweight |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gait Knee Adduction Moment | 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. | Posted | Mean | Standard Deviation | percent body weight (N)*height (m) | baseline or first and only visit. |
|
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Serious and Other (Not Including Serious) Adverse Events were not collected/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Weight | Body mass index between 18 and 25 kg/m^2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas P. Andriacchi, Ph.D. | Stanford University, Palo Alto Veterans Hospital | 650-723-8024 | tandriac@stanford.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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One tube of blood identified with a unique number.
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
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Cartilage Thickness | Medial/lateral thickness ratio | 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. | Posted | Mean | Standard Deviation | mm/mm | baseline or first and only visit. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Overweight | Body mass index between 25 and 30 kg/m^2 | 0 | 0 | 0 | 0 |
| EG002 | Obese | Body mass index between 30 and 50 kg/m^2 | 0 | 0 | 0 | 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |