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Trial record 15 of 1735 for:    psoriasis

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

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ClinicalTrials.gov Identifier: NCT03629639
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Yijing He, Central South University

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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris With Metabolic Disorders Drug: Metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism: A Double-Blind, Randomized, Placebo-Controlled Study
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Metformin
the distributed subjects will be orally administered Metformin 500mg bid lasting for 12 weeks.
Drug: 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.

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




Primary Outcome Measures :
  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 ] [ Time Frame: baseline, 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 :
  1. improvement of dermatology quality of life: Dermatology Life Quality Index [ Time Frame: baseline, Week 12 ]
    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).

  2. The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index [ Time Frame: baseline, Week 12 ]
    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.

  3. 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 [ Time Frame: baseline, 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).

  4. The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg) [ Time Frame: baseline, Week 12 ]
    The clinical marker will be reported with pre- and post-metformin values compared.

  5. The effect of metformin on gut-microbiota profile of pre- and post-metformin samples [ Time Frame: baseline, Week 12 ]

    fecal macrobiotic profile.

    Comparison of gut microbiota in pre-and post-metformin samples.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629639


Contacts
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Contact: Yi Xiao, M.D +8618674823326 xiaoy26@uw.edu

Sponsors and Collaborators
Central South University

Publications:

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Responsible Party: Yijing He, Professor, Central South University
ClinicalTrials.gov Identifier: NCT03629639     History of Changes
Other Study ID Numbers: 2018-MET/CSU/PSO
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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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
Keywords provided by Yijing He, Central South University:
Psoriasis
Metformin
Gut microbiota
Additional relevant MeSH terms:
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Psoriasis
Metabolic Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs