A Real-World Study on the Impact of Weight Loss on Treatment Efficacy in Overweight/Obese Patients With Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Proportion of PASI<3 at Week 24
研究概览
简要总结
The goal of this investigator-initiated, real-world, observational study is to investigate the impact of weight loss on treatment efficacy in overweight or obese Chinese patients with moderate-to-severe plaque psoriasis.
The main question it aims to answer is:
Does a structured weight loss intervention (including dietary management, exercise, and/or pharmacotherapy) improve the clinical response to psoriasis therapy in this population, as measured by the proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24?
Researchers will compare the Weight Loss Intervention Group (receiving standard psoriasis care plus a personalized weight management program) to the Control Group (receiving standard psoriasis care only) to see if the addition of weight loss strategies leads to superior improvements in psoriasis severity, metabolic parameters, and quality of life.
Participants will:
Receive standardized treatment for their psoriasis based on disease severity.
Be allocated (based on patient preference and clinical judgment) to either the intervention or control group.
In the intervention group, receive and follow a personalized weight management plan, which may include dietary counseling, a tailored exercise regimen, and/or Glucagon-Like Peptide-1(GLP-1) receptor agonist therapy (e.g., Semaglutide, Tirzepatide) if indicated.
Undergo scheduled assessments at baseline, Week 12, and Week 24, including:
Clinical evaluations (PASI, Physician's Global Assessment, body surface area).
Anthropometric measurements (weight, BMI, waist/hip circumference).
Quality of life assessment (Dermatology Life Quality Index).
Safety monitoring for adverse events. To investigate the impact of weight loss on treatment efficacy among overweight/obese Chinese patients with plaque psoriasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, regardless of gender.
- •Having signed the informed consent form.
- •Clinical diagnosis of plaque psoriasis.
- •Body Mass Index (BMI) categorized as overweight or obese.
- •For female patients: No plans for pregnancy or oocyte donation during the study period and voluntary use of highly effective physical contraception.
排除标准
- •Pregnant or lactating women.
- •Individuals deemed by the investigator to be unsuitable for participation in this study.
研究组 & 干预措施
Weight Loss Group
receiving standard psoriasis care plus a personalized weight management program
干预措施: Weight loss and psoriasis treatment (Combination Product)
Control Group
receiving standard psoriasis care only
干预措施: psoriasis treatment (Combination Product)
结局指标
主要结局
Proportion of PASI<3 at Week 24
时间窗: Week 24
Proportion of patients undergoing weight loss treatment who achieve a Psoriasis Area and Severity Index (PASI) score below 3 at Week 24.
次要结局
- Proportion of PASI<3 at Week 12(Week 12)
- Changes of BMI(Week 12 and Week 24)
- Proportion of PGA 0/1 (Physician's Global Assessment)(Week 12 and Week 24)
- Proportion of DLQI<6(Week 12 and Week 24)
研究者
Guo Jin-Zhu
associate chief physician
Peking University Third Hospital
