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

Primary Purpose

Psoriasis Vulgaris With Metabolic Disorders

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metformin
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris With Metabolic Disorders focused on measuring Psoriasis, Metformin, Gut microbiota

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Metformin

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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).
    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.
    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).
    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.
    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.

    Full Information

    First Posted
    August 8, 2018
    Last Updated
    August 12, 2018
    Sponsor
    Central South University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03629639
    Brief Title
    Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism
    Acronym
    MPGLM
    Official Title
    Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism: A Double-Blind, Randomized, Placebo-Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    September 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Central South University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis Vulgaris With Metabolic Disorders
    Keywords
    Psoriasis, Metformin, Gut microbiota

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Metformin
    Arm Type
    Experimental
    Arm Description
    the distributed subjects will be orally administered Metformin 500mg bid lasting for 12 weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    the distributed subjects will be orally administered Metformin-like placebo 500mg bid lasting for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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 ]
    Description
    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.
    Time Frame
    baseline, Week 12
    Secondary Outcome Measure Information:
    Title
    improvement of dermatology quality of life: Dermatology Life Quality Index
    Description
    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).
    Time Frame
    baseline, Week 12
    Title
    The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index
    Description
    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.
    Time Frame
    baseline, Week 12
    Title
    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
    Description
    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).
    Time Frame
    baseline, Week 12
    Title
    The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg)
    Description
    The clinical marker will be reported with pre- and post-metformin values compared.
    Time Frame
    baseline, Week 12
    Title
    The effect of metformin on gut-microbiota profile of pre- and post-metformin samples
    Description
    fecal macrobiotic profile. Comparison of gut microbiota in pre-and post-metformin samples.
    Time Frame
    baseline, Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi Xiao, M.D
    Phone
    +8618674823326
    Email
    xiaoy26@uw.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR) can be shared for the purpose of academic communication
    IPD Sharing Time Frame
    Since the official start of the trial to the end of the trial
    IPD Sharing Access Criteria
    Describe clearly about the reason of review.
    Citations:
    PubMed Identifier
    29549478
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28670544
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28538228
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25443628
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23437788
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18194825
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29130553
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23804561
    Citation
    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.
    Results Reference
    background

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

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