An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis

• Conditions: Non-alcoholic Fatty Liver Disease; Psoriasis Chronic; Liver Fibrosis; Fatty Liver
• Interventions: Device: Transient elastography

• Registration Number: NCT02174367
• Lead Sponsor: King's College London

Brief Summary

• Main objectives and outcome measures.

1. Establish prevalence of and factors contributing to fatty liver disease and liver fibrosis in patients with psoriasis.

Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy or non-invasive tests of fibrosis including transient elastography, ultrasound, serum markers of fibrosis including procollagen-3-N-terminal peptide (P3NP).

2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP.

3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic syndrome on response to treatment in patients with psoriasis.

Data on co-morbid disease collected through questionnaires and review of medical records. Response to treatment assessed using psoriasis area and severity index (PASI) physician global assessment (PGA) and dermatology life quality index (DLQI).

* Study population: 380 patients with moderate to severe psoriasis will be prospectively recruited to the study.

* Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine Smith

* Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St Thomas Hospitals Trust

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Status Verified: 2017-06
• Primary Completion: 2017-07
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients who have given written informed consent
• Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.
• 18 yrs. of age

Exclusion Criteria

• Patients who have not given written informed consent
• Patients under 18 yrs. of age
• Patients with a PASI less than 10.
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psoriasis	Transient elastography	Patients with moderate to sever psoriasis attending a tertiary referral center. patients will be evaluated with a questionnaire, measurement of height,weight, waist circumference, fasting bloods, abdominal ultrasound and transient elastography.

Primary Outcome Measures

Name	Time	Method
Number of participants with liver fibrosis.	12 months after enrollment	Liver fibrosis will be assessed by transient elastography and the use of standard liver function tests and other serum markers of fibrosis including P3NP. In a minority of cases fibrosis will be diagnosed by liver biopsy and evaluation of histology. Risk factors for the development of fibrosis including metabolic syndrome, alcohol and methotrexate use will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Number of participants with fatty liver disease diagnosed by ultrasound	Within 12 months of enrollment	Fatty liver disease will be defined by the presence or absence of fatty changes on abdominal ultrasound. Risk factors for the development of fatty liver disease including abdominal obesity, diabetes, and alcohol use will be evaluated.

Trial Locations

Locations (1)

Guys and St Thomas NHS Foundation trust and King's College London; 🇬🇧 London, United Kingdom