Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism: A Double-Blind, Randomized, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 主要终点
- Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 [ Time Frame: Baseline and Week 12 ]
研究概览
简要总结
Psoriasis and metabolic disorders are well-known mutual comorbidities. The investigators hypothesized metformin can ameliorate both psoriasis and metabolic disorders mainly via gut microbiota modulation. The investigators design a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of treatment of metformin for psoriasis combined with disorders of glucose and lipid metabolism and to explore the role of gut microbiota during the process.
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)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •criteria 1 and 2 are both needed for inclusion:
- •included if all of the following criteria are met
- •≥18 years and ≤75 years
- •Diagnosed according to Classification criteria for Psoriasis Vulgaris
- •Understanding the whole process of the study, voluntary participation and signed the informed consent
- •included if at least one of the following criteria is met
- •Body Mass Index (BMI) over 24
- •impaired glucose or insulin resistance
排除标准
- •Pregnant women, or women who ready for pregnancy or lactating;
- •Have special primary endocrine system lesions that can influence glucose or lipid metabolism
- •More than 20% change of their predrug body weight within a half year
- •Severe diabetes which needs combined therapy
- •Known major systemic diseases like cancer, liver or kidney malfunction, etc.
- •Alcohol abuse
- •Known severe or chronic infections like tuberculosis or HIV
- •Use of other systemic medication that could influence the metabolic level
- •Patients participated in any clinical trials within 3 months
- •Other cases which researchers believe that can not enroll
研究组 & 干预措施
Metformin
the distributed subjects will be orally administered Metformin 500mg bid lasting for 12 weeks.
干预措施: Metformin (Drug)
Placebo
the distributed subjects will be orally administered Metformin-like placebo 500mg bid lasting for 12 weeks.
干预措施: Metformin (Drug)
结局指标
主要结局
Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 [ Time Frame: Baseline and Week 12 ]
时间窗: baseline, Week 12
Number of participants achieving greater than or equal to 75 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). Baseline visit refers to Week 0.
次要结局
- The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg)(baseline, Week 12)
- The effect of metformin on gut-microbiota profile of pre- and post-metformin samples(baseline, Week 12)
- improvement of dermatology quality of life: Dermatology Life Quality Index(baseline, Week 12)
- The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index(baseline, Week 12)
- Number of Participants Achieving a Greater Than or Equal to 90 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 90) Score at Week 12(baseline, Week 12)
研究者
Yijing He
Professor
Central South University