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临床试验/NCT01137188
NCT01137188已完成不适用

Effect of Weight Loss on Skin Manifestations, Inflammatory Markers and Risk Factor for Comorbidity in Obese Patients With Psoriasis - a Randomized Cross-over Study

University Hospital, Gentofte, Copenhagen2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010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
60
试验地点
2
主要终点
PASI

研究概览

简要总结

Controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity is correlated with the degree of overweight. No controlled interventional studies reporting on the effect of weight loss on psoriatic skin manifestations have been published and data from case reports are conflicting.

Patients with psoriasis demonstrate an increased susceptibility to atherosclerotic comorbidities such as arterial hypertension, coronary vascular disease, stroke, hyperlipidemia and type II diabetes and in severe psoriasis there is an increased risk of early death. Lately the role of inflammation in the atherosclerotic process has been highlighted and the link between psoriasis and atherosclerosis may be explained by the concomitant systemic inflammation in psoriasis. Similarly a state of low level inflammation is seen in obesity where macrophages and adipocytes begin to show overlap in function and gene expression. This leads to an increased migration of macrophages into the adipose tissue and an increased secretion of pro-inflammatory cytokines. In summary, these data and theoretical considerations suggest that weight loss in obese patients with psoriasis may improve skin manifestations and reduce the risk of atherosclerotic comorbidity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • moderate/severe psoriasis at inclusion or previous to systemic immunosuppressive therapy
  • BMI > 27

排除标准

  • pregnancy/breast feeding
  • diabetes requiring insulin treatment
  • severe heart/kidney/liver disease
  • high potassium intake
  • obesity due to medical conditions/medications
  • use of medical treatment for obesity
  • previous bariatric surgery
  • intentional/unintentional weight loss up to 3 months prior to inclusion

结局指标

主要结局

PASI

时间窗: 16 weeks

Psoriasis area severity index

次要结局

  • Risk factors for comorbidity(16 weeks)

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Jensen

MD

University Hospital, Gentofte, Copenhagen

研究点 (2)

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