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

NCT03629639 | Unknown Phase 4 DMC

• 1 other identifier: 2018-MET/CSU/PSO
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Keywords

Psoriasis; Metformin; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• improvement of dermatology quality of life: Dermatology Life Quality Index

  baseline, Week 12

• The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index

  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

  baseline, Week 12

• The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg)

  baseline, Week 12

• The effect of metformin on gut-microbiota profile of pre- and post-metformin samples

  baseline, Week 12

Study Arms (2)

Metformin

EXPERIMENTAL

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

Drug: Metformin

Placebo

PLACEBO COMPARATOR

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

Drug: Metformin

Interventions

Metformin 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.

Metformin; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Related Publications (8)

• 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.

  PMID: 29549478 BACKGROUND

• 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.

  PMID: 28670544 BACKGROUND

• 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.

  PMID: 28538228 BACKGROUND

• 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.

  PMID: 25443628 BACKGROUND

• 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.

  PMID: 23437788 BACKGROUND

• 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.

  PMID: 18194825 BACKGROUND

• 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.

  PMID: 29130553 BACKGROUND

• 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.

  PMID: 23804561 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Yi Xiao, M.D

CONTACT

+8618674823326; xiaoy26@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 14, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Since the official start of the trial to the end of the trial
• Access Criteria: Describe clearly about the reason of review.