Clinical trial NCT04730557: Reducing Obesity and Cartilage Compression in Knees
Official title: Reducing Obesity and Cartilage Compression in Knees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Osteoarthritis
Knee Osteoarthritis
Keywords: Weight Loss
MRI
Arthritis
Knee Health
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* BMI (BMI ≥29 - \<40)
* Age between 18 - 45

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in cartilage strain/thickness at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Change from baseline in cartilage composition at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in inflammation at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in cartilage degeneration at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in biomarkers of insulin resistance and beta-cell function at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in muscle strength at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in body weight at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in fat mass (kg) at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in fat mass (%) at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in lean mass (%) at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in lean mass (kg) at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in 6-minute walk (meters) at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in umbilical waist circumference at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in minimal waist circumference at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in hip circumference at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline total calories at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline macronutrients at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change in activity (intensity levels) at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change in steps at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Healthy Eating Index at 3 months and 6 months
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lou DeFrate
role: PRINCIPAL_INVESTIGATOR
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