Reducing Obesity and Cartilage Compression in Knees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change from baseline in cartilage strain/thickness at 3 and 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI (BMI ≥29 - <40)
- •Age between 18 - 45
排除标准
- •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
结局指标
主要结局
Change from baseline in cartilage strain/thickness at 3 and 6 months
时间窗: Baseline, 3 months, and 6 months
We will use MRI to detect change in cartilage strain/thickness at 3 and 6 months
次要结局
- Change from baseline in cartilage composition at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in inflammation at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in cartilage degeneration at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in muscle strength at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change in Healthy Eating Index at 3 months and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in body weight at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in fat mass (%) at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in lean mass (kg) at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in umbilical waist circumference at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change in steps at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline macronutrients at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in biomarkers of insulin resistance and beta-cell function at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in lean mass (%) at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in 6-minute walk (meters) at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in hip circumference at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change in activity (intensity levels) at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in fat mass (kg) at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline in minimal waist circumference at 3 and 6 months(Baseline, 3 months, and 6 months)
- Change from baseline total calories at 3 and 6 months(Baseline, 3 months, and 6 months)