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

King's College London

Status: Unknown

Conditions: Fatty Liver; Psoriasis Chronic; Liver Fibrosis; Non-alcoholic Fatty Liver Disease

Treatments: Device: Transient elastography

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02174367

WS1851782

11/LO/1236 (Other Identifier)

Details and patient eligibility

About

• 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

Enrollment: 400 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Psoriasis

Description:

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.

Treatment:

Device: Transient elastography