Psoriasis Vulgaris With Metabolic Disorders Clinical Trial
— MPGLMOfficial title:
Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism: A Double-Blind, Randomized, Placebo-Controlled Study
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.
| Status | Not yet recruiting |
| Enrollment | 80 |
| Est. completion date | December 1, 2020 |
| Est. primary completion date | September 1, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: criteria 1 and 2 are both needed for inclusion: 1. 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 2. 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Central South University |
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |