NCT01460069已完成不适用
The Effect of GLP-1 in Psoriasis
Annesofie Faurschou1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PASI (psoriasis area and severity index)
研究概览
简要总结
The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on psoriasis in a double-blinded, randomized placebo-controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Caucasians above 18 years of age
- •Plaque psoriasis
- •PASI score >10
- •No treatment or stable treatment of psoriasis during at least 3 months before inclusion
- •Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2
- •Normal blood pressure
- •Spiral or hormonal birth control for fertile women during the entire treatment period and at least 3 days after the end of the treatment period (~5 times the plasma half-life)
排除标准
- •Psoriasis arthritis
- •Fasting plasma glucose > 7.5 mmol/L or HbA1c > 7.5%
- •Type 1 diabetes
- •Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists)
- •Heart failure, NYHA class III-IV
- •Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine >150 µM and/or albuminuria
- •Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) >2 x upper normal serum levels)
- •Acute or chronic pancreatitis
- •Struma or thyroid cancer
- •Pregnancy or breast feeding
- •Inability to complete the study
研究组 & 干预措施
Victoza treatment
Active Comparator
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
The placebo pens contain saline and are administered in the same way and volume as Victoza. The placebo pens are specially prepared for this study and will be used in the study only.
干预措施: Placebo (Drug)
结局指标
主要结局
PASI (psoriasis area and severity index)
时间窗: Baseline and after 2 months
DLQI (dermatology life quality index)
时间窗: Baseline and after 2 months
次要结局
- Body mass index(Baseline and after 2 months)
- CRP(Baseline and after 2 months)
- Skin biopsies(Baseline and after 2 months)
研究者
Annesofie Faurschou
MD PhD - Resident in dermatology
University Hospital, Gentofte, Copenhagen
研究点 (1)
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