Clinical trial NCT03629639: Metformin for Treatment of Psoriasis Combined With Disorders of Glucose and Lipid Metabolism
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psoriasis Vulgaris With Metabolic Disorders
Keywords: Psoriasis
Metformin
Gut microbiota
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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 ]
timeFrame: baseline, Week 12
Secondary outcomes:
measure: improvement of dermatology quality of life: Dermatology Life Quality Index
timeFrame: baseline, Week 12
measure: The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index
timeFrame: baseline, Week 12
measure: 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
timeFrame: baseline, Week 12
measure: The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg)
timeFrame: baseline, Week 12
measure: The effect of metformin on gut-microbiota profile of pre- and post-metformin samples
timeFrame: baseline, Week 12
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.