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

August 12, 2018 updated by: Yijing He, Central South University

Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism: A Double-Blind, Randomized, Placebo-Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yi Xiao, M.D
  • Phone Number: +8618674823326
  • Email: xiaoy26@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline, Week 12
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.
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
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).
baseline, Week 12
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.
baseline, Week 12
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.
baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 12, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 12, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-MET/CSU/PSO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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