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