Biomarkers in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in collagen II degradation fragment α-C2M
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).
This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention
详细描述
In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which they 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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)
排除标准
- •Same as parent trial (NCT02905864)
研究组 & 干预措施
Intensive dietary intervention
Supervised dietary weight loss program lasting 8 weeks
干预措施: Dietary Supplement: Dietary Supplement: Intensive dietary intervention (Dietary Supplement)
结局指标
主要结局
Change in collagen II degradation fragment α-C2M
时间窗: Week -8 to 0
Blood sampling
次要结局
- Change in non-coding RNA type snoRNAs U38 and U48(Week -8 to 0)
- Change in miRNA-454(Week -8 to 0)
- Change in miRNA let-7e(Week -8 to 0)
- Change in Nesfatin-1(Week -8 to 0)
- Change in collagen II degradation fragment β-C2M(Week -8 to 0)
研究者
Henrik Gudbergsen
MD, PhD
Parker Research Institute