跳至主要内容
临床试验/NCT02917434
NCT02917434已完成不适用

Effects of Weight-loss Treatment in Obese Patients With Psoriatic Arthritis

Vastra Gotaland Region8 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年4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
90
试验地点
8
主要终点
Minimal Disease Activity (MDA) which is a composite outcome measure

研究概览

简要总结

The study is an open intervention study with the aim to determine the effects of weight-loss treatment with Low-Energy liquid Diet (LED) on disease activity, quality of life and markers of the metabolic syndrome in patients with psoriatic arthritis and obesity.

详细描述

BACKGROUND Psoriasis is a common skin disease affecting around 2-3% of the population in Sweden. Approximately 20-30% of the individuals with psoriasis develop psoriatic arthritis (PsA). PsA mainly engage the musculoskeletal apparatus and causes inflammation of joints, tendons and ligaments, but the disease also increases the risk of developing anterior uveitis and inflammatory bowel disease, especially Crohn's disease.

Both psoriasis and PsA are strongly associated with obesity and the metabolic syndrome (Mets). Observational studies have reported a frequency of obesity (body mass index; BMI≥30 kg/m2) in 45% and of MetS in 30-45% of PsA patients. Earlier studies have shown that obesity increases the risk of developing both psoriasis and PsA and that obesity is associated with increased disease activity, poorer treatment response and lower chance of achieving minimal disease activity.

Although the association between PsA and obesity is well known, there are only a small number of interventional studies which have assessed the effects of weight loss on disease activity in PsA.

Patients with PsA also have an increased risk of cardiovascular disease. [12, 13] Chronic inflammation, which accelerates the atherosclerotic process, in combination with a higher prevalence of cardiovascular risk factors among PsA patients is believed to contribute to this increased risk.

Obesity causes a low grade systemic inflammation via the production of pro-inflammatory mediators in the white adipose tissue, such as adipokines and cytokines (e.g. tumour necrosis factor-α and interleukin-6), which are also involved in the pathogenic process if PsA. Obesity-related inflammation could thus act synergistically with autoimmune inflammation in the development and the maintenance of disease in psoriasis and PsA.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PsA fulfilling the Classification for Psoriatic Arthritis (CASPAR) criteria
  • BMI≥33 kg/m2
  • Age 18-75 years

排除标准

  • Pregnancy
  • Porphyria
  • Diabetes type 1
  • Severe heart or kidney disease
  • Eating disorder
  • Severe catabolic disease

结局指标

主要结局

Minimal Disease Activity (MDA) which is a composite outcome measure

时间窗: 6 months

5 of 7 of the following criteria: Tender joint count ≤ 1 Swollen joint count ≤ 1 PASI ≤ 1or BSA ≤ 3 Patient pain VAS ≤ 15 Patient global activity VAS ≤ 20 HAQ ≤ 0.5 Tender entheseal points ≤ 1 BSA: body surface area; HAQ: Health Assessment Questionnaire; PASI

次要结局

未报告次要终点

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (8)

Loading locations...

相似试验