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

NCT ID: NCT03629639

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-12-01

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.

Conditions

Psoriasis Vulgaris With Metabolic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metformin

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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Metformin

Intervention Type: DRUG

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.

Interventions

Metformin

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Yijing He

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yi Xiao, M.D

Role: CONTACT

xiaoy26@uw.edu

+8618674823326

References

Wang X, Li R, Zhao X, Yu X, Sun Q. Metformin Promotes HaCaT Cell Apoptosis through Generation of Reactive Oxygen Species via Raf-1-ERK1/2-Nrf2 Inactivation. Inflammation. 2018 Jun;41(3):948-958. doi: 10.1007/s10753-018-0749-z.

Reference Type: BACKGROUND

PMID: 29549478 (View on PubMed)

Singh S, Bhansali A. Randomized Placebo Control Study of Metformin in Psoriasis Patients with Metabolic Syndrome (Systemic Treatment Cohort). Indian J Endocrinol Metab. 2017 Jul-Aug;21(4):581-587. doi: 10.4103/ijem.IJEM_46_17.

Reference Type: BACKGROUND

PMID: 28670544 (View on PubMed)

Ip W, Kirchhof MG. Glycemic Control in the Treatment of Psoriasis. Dermatology. 2017;233(1):23-29. doi: 10.1159/000472149. Epub 2017 May 25.

Reference Type: BACKGROUND

PMID: 28538228 (View on PubMed)

Wu CY, Shieh JJ, Shen JL, Liu YY, Chang YT, Chen YJ. Association between antidiabetic drugs and psoriasis risk in diabetic patients: results from a nationwide nested case-control study in Taiwan. J Am Acad Dermatol. 2015 Jan;72(1):123-30. doi: 10.1016/j.jaad.2014.08.042. Epub 2014 Oct 16.

Reference Type: BACKGROUND

PMID: 25443628 (View on PubMed)

Badr D, Kurban M, Abbas O. Metformin in dermatology: an overview. J Eur Acad Dermatol Venereol. 2013 Nov;27(11):1329-35. doi: 10.1111/jdv.12116. Epub 2013 Feb 26.

Reference Type: BACKGROUND

PMID: 23437788 (View on PubMed)

Brauchli YB, Jick SS, Curtin F, Meier CR. Association between use of thiazolidinediones or other oral antidiabetics and psoriasis: A population based case-control study. J Am Acad Dermatol. 2008 Mar;58(3):421-9. doi: 10.1016/j.jaad.2007.11.023. Epub 2008 Jan 14.

Reference Type: BACKGROUND

PMID: 18194825 (View on PubMed)

Tan L, Zhao S, Zhu W, Wu L, Li J, Shen M, Lei L, Chen X, Peng C. The Akkermansia muciniphila is a gut microbiota signature in psoriasis. Exp Dermatol. 2018 Feb;27(2):144-149. doi: 10.1111/exd.13463.

Reference Type: BACKGROUND

PMID: 29130553 (View on PubMed)

Shin NR, Lee JC, Lee HY, Kim MS, Whon TW, Lee MS, Bae JW. An increase in the Akkermansia spp. population induced by metformin treatment improves glucose homeostasis in diet-induced obese mice. Gut. 2014 May;63(5):727-35. doi: 10.1136/gutjnl-2012-303839. Epub 2013 Jun 26.

Reference Type: BACKGROUND

PMID: 23804561 (View on PubMed)

Other Identifiers

2018-MET/CSU/PSO

Identifier Type: -

Identifier Source: org_study_id