A Single-arm Trial to Evaluate the Efficacy of an Aggressive Weight Loss Program With a Ketogenic Induction Phase for the Treatment of Chronic Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Reduction in Psoriasis Area and Severity Index
研究概览
简要总结
Chronic plaque psoriasis is frequently associated with obesity and previous studies have shown that a calorie-controlled diet inducing body weight loss improves symptoms and increases the response to pharmacologic treatment. Besides, clinical improvement has been directly correlated with the amount of weight loss. Short-term very low-calorie ketogenic diets are responsible for substantial weight loss and attenuate systemic inflammation to a higher extent than moderately hypocaloric diets. This intervention has been recently demonstrated to restore, after only 4 week, the response to biological therapy in a patient suffering from relapsing moderate-to-severe plaque psoriasis and obesity-related metabolic syndrome. We investigated the efficacy of an aggressive weight loss program with a ketogenic induction phase in a single-arm trial that could provide the rationale for a large randomized trial.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable chronic plaque psoriasis
- •Overweight/obese (body mass index >25 kg/m2)
排除标准
- •pregnancy and/or lactation
- •insulin-dependent diabetes mellitus
- •a psychiatric disorder
- •current or previous (<1 year since last chemo- or radiotherapy) neoplastic disease
- •established vascular disease
- •recent (6 months), history of diet-induced or unintentional weight loss
- •moderate-to-severe heart failure
- •arrhythmia or conduction disorder
- •renal failure (creatinine >1.5 mg/dL)
- •liver failure (Child-Pugh ≥ A)
- •any type of gastrointestinal disease
- •moderate-severe hypoalbuminemia (<3.0 g/dL)
- •altered serum electrolytes
- •refusal to give written informed consent
研究组 & 干预措施
Experimental
A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet
干预措施: Diet (Other)
结局指标
主要结局
Reduction in Psoriasis Area and Severity Index
时间窗: 10 weeks
Change in score (on continuous scale) at the end of study
次要结局
- Reduction in body surface area(4 weeks)
- Reduction in Psoriasis Area and Severity Index(4 weeks)
- Reduction in Psoriasis Area and Severity Index >=75%(4 weeks)
- Reduction in Psoriasis Area and Severity Index >=50%(4 weeks)
- Reduction in Dermatology Life Quality Index (DLQI)(4 weeks)
- Reduction in itch severity(4 weeks)
- Reduction in body weight(4 weeks)
- Reduction in Visceral fat(4 weeks)
研究者
Giuseppe Castaldo
Principal Investigator
San Giuseppe Moscati Hospital