ObesityROCCKNCT04730557
Reducing Obesity and Cartilage Compression in Knees
A study testing Weight Loss in people with Obesity and Osteoarthritis, run by Duke University at 1 site in United States.
Trial summary
OA is a degenerative joint disease that involves the degradation of articular cartilage and underlying subchondral bone. Obesity is identified as a critical and potentially modifiable risk factor for the development and progression of OA. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2020to 17 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI (BMI ≥29 - <40)
- Age between 18 - 45
Who cannot join
- History of lower extremity injury
- Evidence of symptoms of knee OA
- Knee misalignment
- Evidence of pregnancy
- Thigh unable to fit in MRI coil
- Body waist fit in MRI
- Have no metals in the body
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
OA is a degenerative joint disease that involves the degradation of articular cartilage and underlying subchondral bone. Obesity is identified as a critical and potentially modifiable risk factor for the development and progression of OA. The first objective of the study is to determine the effects of obesity on cartilage composition and function. The second objective of the study is to determine whether weight loss restores cartilage composition and function. Study activities would require getting MR Imaging, evaluation of joint loading using gait analysis techniques, cartilage strain measurement, and participating in weight loss intervention. The study will target a population age group between 18 and 45 years with a BMI greater than or equal to 29. Data analyses will be blinded to reduce potential bias. All subjects participating in this study will be informed of the risks involved and sign an IRB-approved consent form.
Read the detailed description
Appropriate study power will be achieved with 35 participants in the weight loss group and 35 participants in the weight maintenance control group (see Data Analysis and Statistical Considerations). We will recruit and enroll obese (BMI ≥29 - ≤40) men and women, age 18 to 45, with no previous history of lower extremity injury, no evidence of symptoms OA, no knee misalignment (neutral alignment between 178° and 182°), or other injury that would prevent them from performing the walking task required by this study. All inclusion criteria specific to knee injury, OA, and alignment will be verified by MRI scan. All participants in this study will be informed of the risks involved. Upon expressing interest in study participation, participants will be asked questions to determine whether they are free of lower extremity injury and their height and weight will also be recorded to determine their BMI. Potential participants will be pre-screened by phone using a phone script with a list of questions. Once it is determined they meet all study inclusion criteria, they will be invited to attend a consent meeting.
- Conditions
- Obesity, Osteoarthritis, Knee Osteoarthritis
- Being tested
- Weight Loss
- Keywords
- Weight Loss, MRI, Arthritis, Knee Health
- Medical subject headings
- Obesity, Osteoarthritis, Osteoarthritis, Knee, Weight Loss, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight LossBehavioural
Each participant receives a calorie (kcal) prescription derived from calculations of estimated total energy expenditure (TEE) based on weight, height, sex, age, and activity level using equations developed by the Institute of Medicine [29]. Prescribed kcal levels are adjusted downward from the TEE to achieve a weekly weight loss of 1 to 2 pounds, generally a deficit of 500-1000 kcal/day. Weekly intervention sessions and activities will be delivered virtually using Microsoft Teams, Duke ZOOM or Duke Webex and led by Registered Dietitians.
| Study group | Role | What they receive |
|---|---|---|
| Weight-Loss | Experimental | Participants in the weight-loss intervention arm of the study will be enrolled in an individualized 6-month intervention designed to achieve a 10% reduction of body weight relative to baseline. Each participant receives a calorie (kcal) prescription derived from calculations of estimated total energy expenditure (TEE) based on weight, height, sex, age, and activity level using equations developed by the Institute of Medicine [29]. Prescribed kcal levels are adjusted downward from the TEE to achieve a weekly weight loss of 1 to 2 pounds, generally a deficit of 500-1000 kcal/day. Intervention activities include individual diet counseling, group support, goal setting, self-monitoring, stress management, and problem solving. Weekly group support and education sessions, along with daily food journaling and weekly weigh-ins, are recognized approaches for successful weight loss [30-32]. Once the weight loss goal is achieved, diets will be liberalized for weight maintenance. Receives: Behavioral: Weight Loss |
| Wellness Education | No intervention | Control participants will be counseled to maintain their baseline body weight and level of physical activity. They will report weights weekly and if their weight deviates from baseline they will be asked to keep daily food logs and counseled to return calorie intakes to weight maintenance level. To document diet intakes/adherence, 3-day food records will be collected at months 0, 3, and 6 and analyzed for calorie and nutrient composition. Participants will be encouraged not to change their physical activity levels from baseline and their activity will be monitored by Actigraph activity monitors worn in 7-day periods at months 0, 3, and 6. In addition, each participant will be invited to enter the weight loss intervention after completion of the health education control course. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cartilage strain/thickness at 3 and 6 months
We will use MRI to detect change in cartilage strain/thickness at 3 and 6 months
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (19)
Change from baseline in cartilage composition at 3 and 6 months
We will use MRI to detect change in cartilage composition at 3 and 6 months
Measured: Baseline, 3 months, and 6 months
Change from baseline in inflammation at 3 and 6 months
Serum and urine biomarkers will be collected to determine levels of inflammation.
Measured: Baseline, 3 months, and 6 months
Change from baseline in cartilage degeneration at 3 and 6 months
We will use serum biomarkers to determine cartilage degeneration
Measured: Baseline, 3 months, and 6 months
Change from baseline in biomarkers of insulin resistance and beta-cell function at 3 and 6 months
We will use serum biomarkers to determine insulin resistance and beta-cell function
Measured: Baseline, 3 months, and 6 months
Change from baseline in muscle strength at 3 and 6 months
Isokinetic dynamometer will be used to determine peak torque of knee extensor and flexor
Measured: Baseline, 3 months, and 6 months
Change from baseline in body weight at 3 and 6 months
Body weight as measured by Bodpod
Measured: Baseline, 3 months, and 6 months
Change from baseline in fat mass (kg) at 3 and 6 months
Body fat mass (kg) as measured by Bodpod
Measured: Baseline, 3 months, and 6 months
Change from baseline in fat mass (%) at 3 and 6 months
Body fat mass (%) as measured by Bodpod
Measured: Baseline, 3 months, and 6 months
Change from baseline in lean mass (%) at 3 and 6 months
Body lean mass (%) as measured by Bodpod
Measured: Baseline, 3 months, and 6 months
Change from baseline in lean mass (kg) at 3 and 6 months
Body lean mass (%) as measured by Bodpod
Measured: Baseline, 3 months, and 6 months
Change from baseline in 6-minute walk (meters) at 3 and 6 months
Distanced (meters) walked in 6 minutes
Measured: Baseline, 3 months, and 6 months
Change from baseline in umbilical waist circumference at 3 and 6 months
Body proportions will be measured at the umbilical waist using a Gulick II tape measure with the tape placed directly on the skin (not over clothes). Measurement will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are >0.5 cm.
Measured: Baseline, 3 months, and 6 months
Change from baseline in minimal waist circumference at 3 and 6 months
Body proportions will be measured at the minimal waist using a Gulick II tape measure with the tape placed directly on the skin (not over clothes). Measurement will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are >0.5 cm.
Measured: Baseline, 3 months, and 6 months
Change from baseline in hip circumference at 3 and 6 months
Body proportions will be measured at the hip circumference using a Gulick II tape measure with the tape placed directly on the skin (not over clothes). Measurement will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are >0.5 cm.
Measured: Baseline, 3 months, and 6 months
Change from baseline total calories at 3 and 6 months
Total calories will be measured using a 3-day food record (participant records everything they eat and drink for three days)
Measured: Baseline, 3 months, and 6 months
Change from baseline macronutrients at 3 and 6 months
Total calories will be measured using a 3-day food record (participant records everything they eat and drink for three days)
Measured: Baseline, 3 months, and 6 months
Change in activity (intensity levels) at 3 and 6 months
Activity intensity levels using an actigraphy device worn for 7 days at each time point
Measured: Baseline, 3 months, and 6 months
Change in steps at 3 and 6 months
Steps will be determined using an actigraphy device worn for 7 days at each time point
Measured: Baseline, 3 months, and 6 months
Change in Healthy Eating Index at 3 months and 6 months
Healthy Eating Index (HEI-2015) calculated from Dietary History Questionnaire III (DHQIII, National Cancer Institute) at each time point. The HEI score ranges from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans..
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start5 Jun 2020
- Primary completion26 Oct 2023
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lou DeFrate, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730557
- Sponsor's protocol ID
- Pro00102409
- Acronym
- ROCCK
- Status last verified
- Jun 2024
- First submitted
- 26 Jan 2021
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
PubMed 18163497Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24.
PubMed 21907813Kopec JA, Rahman MM, Berthelot JM, Le Petit C, Aghajanian J, Sayre EC, Cibere J, Anis AH, Badley EM. Descriptive epidemiology of osteoarthritis in British Columbia, Canada. J Rheumatol. 2007 Feb;34(2):386-93. Epub 2006 Dec 15.
PubMed 17183616Goldring SR, Goldring MB. Bone and cartilage in osteoarthritis: is what's best for one good or bad for the other? Arthritis Res Ther. 2010;12(5):143. doi: 10.1186/ar3135. Epub 2010 Oct 19.
PubMed 21044355Day JS, Ding M, van der Linden JC, Hvid I, Sumner DR, Weinans H. A decreased subchondral trabecular bone tissue elastic modulus is associated with pre-arthritic cartilage damage. J Orthop Res. 2001 Sep;19(5):914-8. doi: 10.1016/S0736-0266(01)00012-2.
PubMed 11562141Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.
PubMed 17719803Ringdahl E, Pandit S. Treatment of knee osteoarthritis. Am Fam Physician. 2011 Jun 1;83(11):1287-92.
PubMed 21661710Kretzer JP, Jakubowitz E, Sonntag R, Hofmann K, Heisel C, Thomsen M. Effect of joint laxity on polyethylene wear in total knee replacement. J Biomech. 2010 Apr 19;43(6):1092-6. doi: 10.1016/j.jbiomech.2009.12.016. Epub 2010 Jan 13.
PubMed 20074735Lahuec C, Almouahed S, Arzel M, Gupta D, Hamitouche C, Jezequel M, Stindel E, Roux C. A self-powered telemetry system to estimate the postoperative instability of a knee implant. IEEE Trans Biomed Eng. 2011 Mar;58(3):822-5. doi: 10.1109/TBME.2010.2069099. Epub 2010 Aug 30.
PubMed 20805049Felson DT. Relation of obesity and of vocational and avocational risk factors to osteoarthritis. J Rheumatol. 2005 Jun;32(6):1133-5. No abstract available.
PubMed 15977343Griffin TM, Guilak F. Why is obesity associated with osteoarthritis? Insights from mouse models of obesity. Biorheology. 2008;45(3-4):387-98.
PubMed 18836239Browning RC, Kram R. Effects of obesity on the biomechanics of walking at different speeds. Med Sci Sports Exerc. 2007 Sep;39(9):1632-41. doi: 10.1249/mss.0b013e318076b54b.
PubMed 17805097Englund M, Lohmander LS. Risk factors for symptomatic knee osteoarthritis fifteen to twenty-two years after meniscectomy. Arthritis Rheum. 2004 Sep;50(9):2811-9. doi: 10.1002/art.20489.
PubMed 15457449Felson DT. Does excess weight cause osteoarthritis and, if so, why? Ann Rheum Dis. 1996 Sep;55(9):668-70. doi: 10.1136/ard.55.9.668. No abstract available.
PubMed 8882146Felson DT. Weight and osteoarthritis. Am J Clin Nutr. 1996 Mar;63(3 Suppl):430S-432S. doi: 10.1093/ajcn/63.3.430.
PubMed 8615335
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Obesity and Cartilage Compression in Knees
- ClinicalTrials.gov ID
- NCT04730557
- Acronym / sponsor ID
- ROCCK / Pro00102409
- Conditions
- Obesity, Osteoarthritis, Knee Osteoarthritis
- Keywords
- Weight Loss, MRI, Arthritis, Knee Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OA is a degenerative joint disease that involves the degradation of articular cartilage and underlying subchondral bone. Obesity is identified as a critical and potentially modifiable risk factor for the development and progression of OA. The first objective of the study is to determine the effects of obesity on cartilage composition and function. The second objective of the study is to determine whether weight loss restores cartilage composition and function. Study activities would require getting MR Imaging, evaluation of joint loading using gait analysis techniques, cartilage strain measurement, and participating in weight loss intervention. The study will target a population age group between 18 and 45 years with a BMI greater than or equal to 29. Data analyses will be blinded to reduce potential bias. All subjects participating in this study will be informed of the risks involved and sign an IRB-approved consent form.
Detailed description
Appropriate study power will be achieved with 35 participants in the weight loss group and 35 participants in the weight maintenance control group (see Data Analysis and Statistical Considerations). We will recruit and enroll obese (BMI ≥29 - ≤40) men and women, age 18 to 45, with no previous history of lower extremity injury, no evidence of symptoms OA, no knee misalignment (neutral alignment between 178° and 182°), or other injury that would prevent them from performing the walking task required by this study. All inclusion criteria specific to knee injury, OA, and alignment will be verified by MRI scan. All participants in this study will be informed of the risks involved. Upon expressing interest in study participation, participants will be asked questions to determine whether they are free of lower extremity injury and their height and weight will also be recorded to determine their BMI. Potential participants will be pre-screened by phone using a phone script with a list of questions. Once it is determined they meet all study inclusion criteria, they will be invited to attend a consent meeting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-Loss | Experimental | Behavioral: Weight LossParticipants in the weight-loss intervention arm of the study will be enrolled in an individualized 6-month intervention designed to achieve a 10% reduction of body weight relative to baseline. Each participant receives a calorie (kcal) prescription derived from calculations of estimated total energy expenditure (TEE) based on weight, height, sex, age, and activity level using equations developed by the Institute of Medicine [29]. Prescribed kcal levels are adjusted downward from the TEE to achieve a weekly weight loss of 1 to 2 pounds, generally a deficit of 500-1000 kcal/day. Intervention activities include individual diet counseling, group support, goal setting, self-monitoring, stress management, and problem solving. Weekly group support and education sessions, along with daily food journaling and weekly weigh-ins, are recognized approaches for successful weight loss [30-32]. Once the weight loss goal is achieved, diets will be liberalized for weight maintenance. |
| Wellness Education | No intervention | –Control participants will be counseled to maintain their baseline body weight and level of physical activity. They will report weights weekly and if their weight deviates from baseline they will be asked to keep daily food logs and counseled to return calorie intakes to weight maintenance level. To document diet intakes/adherence, 3-day food records will be collected at months 0, 3, and 6 and analyzed for calorie and nutrient composition. Participants will be encouraged not to change their physical activity levels from baseline and their activity will be monitored by Actigraph activity monitors worn in 7-day periods at months 0, 3, and 6. In addition, each participant will be invited to enter the weight loss intervention after completion of the health education control course. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI (BMI ≥29 - <40)
- Age between 18 - 45
Key exclusion criteria (7 listed)
- History of lower extremity injury
- Evidence of symptoms of knee OA
- Knee misalignment
- Evidence of pregnancy
- Thigh unable to fit in MRI coil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight LossEach participant receives a calorie (kcal) prescription derived from calculations of estimated total energy expenditure (TEE) based on weight, height, sex, age, and activity level using equations developed by the Institute of Medicine [29]. Prescribed kcal levels are adjusted downward from the TEE to achieve a weekly weight loss of 1 to 2 pounds, generally a deficit of 500-1000 kcal/day. Weekly intervention sessions and activities will be delivered virtually using Microsoft Teams, Duke ZOOM or Duke Webex and led by Registered Dietitians. | Behavioural | Weight-Loss |
Primary outcome
Change from baseline in cartilage strain/thickness at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
We will use MRI to detect change in cartilage strain/thickness at 3 and 6 months
19 secondary outcomes
Change from baseline in cartilage composition at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in inflammation at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in cartilage degeneration at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in biomarkers of insulin resistance and beta-cell function at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in muscle strength at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in body weight at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in fat mass (kg) at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in fat mass (%) at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in lean mass (%) at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in lean mass (kg) at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in 6-minute walk (meters) at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in umbilical waist circumference at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in minimal waist circumference at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in hip circumference at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline total calories at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline macronutrients at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change in activity (intensity levels) at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change in steps at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change in Healthy Eating Index at 3 months and 6 months
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Background: PubMed 18163497Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
- Background: PubMed 21907813Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24.
- Background: PubMed 17183616Kopec JA, Rahman MM, Berthelot JM, Le Petit C, Aghajanian J, Sayre EC, Cibere J, Anis AH, Badley EM. Descriptive epidemiology of osteoarthritis in British Columbia, Canada. J Rheumatol. 2007 Feb;34(2):386-93. Epub 2006 Dec 15.
- Background: PubMed 21044355Goldring SR, Goldring MB. Bone and cartilage in osteoarthritis: is what's best for one good or bad for the other? Arthritis Res Ther. 2010;12(5):143. doi: 10.1186/ar3135. Epub 2010 Oct 19.
- Background: PubMed 11562141Day JS, Ding M, van der Linden JC, Hvid I, Sumner DR, Weinans H. A decreased subchondral trabecular bone tissue elastic modulus is associated with pre-arthritic cartilage damage. J Orthop Res. 2001 Sep;19(5):914-8. doi: 10.1016/S0736-0266(01)00012-2.
- Background: PubMed 17719803Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.
- Background: PubMed 21661710Ringdahl E, Pandit S. Treatment of knee osteoarthritis. Am Fam Physician. 2011 Jun 1;83(11):1287-92.
- Background: PubMed 20074735Kretzer JP, Jakubowitz E, Sonntag R, Hofmann K, Heisel C, Thomsen M. Effect of joint laxity on polyethylene wear in total knee replacement. J Biomech. 2010 Apr 19;43(6):1092-6. doi: 10.1016/j.jbiomech.2009.12.016. Epub 2010 Jan 13.
- Background: PubMed 20805049Lahuec C, Almouahed S, Arzel M, Gupta D, Hamitouche C, Jezequel M, Stindel E, Roux C. A self-powered telemetry system to estimate the postoperative instability of a knee implant. IEEE Trans Biomed Eng. 2011 Mar;58(3):822-5. doi: 10.1109/TBME.2010.2069099. Epub 2010 Aug 30.
- Background: PubMed 15977343Felson DT. Relation of obesity and of vocational and avocational risk factors to osteoarthritis. J Rheumatol. 2005 Jun;32(6):1133-5. No abstract available.
- Background: PubMed 18836239Griffin TM, Guilak F. Why is obesity associated with osteoarthritis? Insights from mouse models of obesity. Biorheology. 2008;45(3-4):387-98.
- Background: PubMed 17805097Browning RC, Kram R. Effects of obesity on the biomechanics of walking at different speeds. Med Sci Sports Exerc. 2007 Sep;39(9):1632-41. doi: 10.1249/mss.0b013e318076b54b.
- Individual participant dataSharing planned: No
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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.
Lou DeFrate principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss in people with Obesity and Osteoarthritis, run by Duke University 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 2 inclusion and 7 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 6 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in cartilage strain/thickness at 3 and 6 months (time frame: Baseline, 3 months, and 6 months). 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 NCT04730557, which also lists 31 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 6 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.