Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss, Investigating the Impact on Inflammation (A Substudy to "Effect of Liraglutide on Body Weight and Pain in Overweight or Obese Patients With Knee Osteoarthritis: A Randomised, Double Blind, Placebo-controlled, Parallel Group, Single-centre Trial" (NCT02905864)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in the degree of inflammation in the knee-joint (DCE-MRI)
研究概览
简要总结
This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which. Patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.
This substudy aims to investigate any changes in MRI associated with the initial 8-week weight loss intervention, and the value of CT scans in predicting the effect of weight loss.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Same as parent trial (NCT02905864)
- •Further Exclusion Criteria
- •Same as parent trial (NCT02905864)
- •Usual exclusion criteria for MRI (i.e. pacemakers etc.)
排除标准
- 未提供
结局指标
主要结局
Change in the degree of inflammation in the knee-joint (DCE-MRI)
时间窗: Week -8 to 0
Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.)
次要结局
- Change in the degree of inflammation in the knee-joint (MRI)(Week -8 to 0)
- Change in cartilage composition(Week -8 to 0)
- Change in the degree of inflammation in the knee-joint (CE-MRI)(Week -8 to 0)
- Prediction of clinical symptoms (KOOS pain) by the level of crystal deposition on dual-energy CT at week 0(Week 0)
- Change in bone marrow lesions (BML)(Week -8 to 0)
研究者
Henrik Gudbergsen
MD, PhD
Parker Research Institute
