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

Central South University

Status and phase: Unknown; Phase 4

Conditions: Psoriasis Vulgaris With Metabolic Disorders

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03629639

2018-MET/CSU/PSO

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

the distributed subjects will be orally administered Metformin 500mg bid lasting for 12 weeks.

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

the distributed subjects will be orally administered Metformin-like placebo 500mg bid lasting for 12 weeks.

Treatment:

Drug: Metformin