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临床试验/NCT00938808
NCT00938808已完成不适用

Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study

Henning Bliddal2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
154
试验地点
2
主要终点
Weight, number of patients operated with knee alloplasty

研究概览

简要总结

Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.

The two diseases intertwine in several ways. The evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. The two diseases share pathogenetic features and the development of one disease increases the risk of the other and may be the onset of a vicious circle.

There is a link between treatments of these two diseases as well. There is now solid (gold) evidence that by treating effectively the obesity of patients with co-occurring OA, the functional status is dramatically ameliorated; the short-term results are equal to that of a joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is definitely one of many diseases in which obesity must be taken seriously into account when planning a correct treatment of patients. This trial is an extension of the former CAROT trial NCT00655941. The participants of this trial are recruited for a prolongation of the dietary intervention consisting of a group therapy with low-energy diet in a randomized, two group (each n = 75 patients) study of maintenance of weight loss by continuing with supplementary either 3 x 5 weeks dietary supplements only or once-daily supplement. The hypothesis is that maintenance of the already induced weight loss is most efficiently ensured by the once-daily program.

详细描述

Any patient with osteoarthritis (OA) of the knee was invited to participate in the preceding trial. Eligible for this study will be patients, who have completed the one-year phase 2 of the CAROT. Exclusion criteria are planned knee alloplasty of both knees.

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
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Former participant in the CAROT study ( NCT00655941 )

排除标准

  • Bilateral knee alloplasty -

结局指标

主要结局

Weight, number of patients operated with knee alloplasty

时间窗: 1 year, 3 years

次要结局

  • Gait analysis(1 year, 3 years)
  • MRI(1 year, 3 years)
  • Collagen markers(1 year, 3 years)
  • KOOS(1 year, 3 years)
  • Metabolic syndrome(1 year, 3 years)
  • Ultrasound(1 year, 3 years)

研究者

发起方
Henning Bliddal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Henning Bliddal

Professor

Frederiksberg University Hospital

研究点 (2)

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