Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism
- Registration Number
- NCT03629639
- Lead Sponsor
- Central South University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin Metformin the distributed subjects will be orally administered Metformin 500mg bid lasting for 12 weeks. Placebo Metformin the distributed subjects will be orally administered Metformin-like placebo 500mg bid lasting for 12 weeks.
- Primary Outcome Measures
Name Time Method 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 ] 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.
- Secondary Outcome Measures
Name Time Method The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg) baseline, Week 12 The clinical marker will be reported with pre- and post-metformin values compared.
The effect of metformin on gut-microbiota profile of pre- and post-metformin samples baseline, Week 12 fecal macrobiotic profile.
Comparison of gut microbiota in pre-and post-metformin samples.improvement of dermatology quality of life: Dermatology Life Quality Index baseline, Week 12 Evaluated by Dermatology Life Quality Index(DLQI). DLQI is the widely used tool for the measurement of skin-health-related quality of life. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages.This is a scale of how bad a person's skin disease affecting his/her life. The scale ranges from 0 (best) -10 (worst).
The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index baseline, Week 12 HOMA index is calculated from serum glucose and insulin. The marker of glucose and insulin metabolism will be reported with pre- and post-metformin values compared.
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 Number of participants achieving greater than or equal to 90 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).