Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism

Study Overview
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Brief Summary
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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.

Official Title
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Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism: A Double-Blind, Randomized, Placebo-Controlled Study

Conditions
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Psoriasis Vulgaris With Metabolic Disorders

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>the distributed subjects will be orally administered Metformin 500mg bid lasting for 12 weeks. | Drug: Metformin<br>* An intervention of either metformin or placebo 500mg twice daily plus standard care for 12 weeks. Besides Metformin, standardized topical treatment is given to all patients; For severe psoriasis patients(PASI>8), Methotrexate will be treated orally 7.5mg every week for both the intervention group and the placebo group as a systemic standard care.<br>|
| Placebo Comparator: Placebo<br>the distributed subjects will be orally administered Metformin-like placebo 500mg bid lasting for 12 weeks. | Drug: Metformin<br>* An intervention of either metformin or placebo 500mg twice daily plus standard care for 12 weeks. Besides Metformin, standardized topical treatment is given to all patients; For severe psoriasis patients(PASI>8), Methotrexate will be treated orally 7.5mg every week for both the intervention group and the placebo group as a systemic standard care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ] | 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. | baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of dermatology quality of life: Dermatology Life Quality Index | 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). | baseline, Week 12 | 
| The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index | 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. | 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 | 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). | baseline, Week 12 | 
| The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg) | The clinical marker will be reported with pre- and post-metformin values compared. | baseline, Week 12 | 
| The effect of metformin on gut-microbiota profile of pre- and post-metformin samples | fecal macrobiotic profile. Comparison of gut microbiota in pre-and post-metformin samples. | baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Metformin, Gut microbiota