A Case Control Study Evaluating the Prevalence of Non-Alcoholic Fatty Liver Disease Among Patients With Psoriasis

A Case Control Study to Evaluate the Prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) Among Patients With Psoriasis

Main objectives

1. Establish the association of psoriasis and the presence of NAFLD in the patients with psoriasis attending dermatologic clinic center.

Secondary objective

1. Evaluate for the presence of other components metabolic syndrome in this group of patients including hypercholesterolemia, hypertension, obesity, and insulin resistance
2. Determine if there is an association between the extent and severity of psoriasis and the presence of NAFLD.
3. Identify an association between BMI and presence of NAFLD in people with psoriasis and use it as a predictive index for primary screening of NAFLD in psoriatic patients.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Nonalcoholic Fatty Liver Disease

Detailed Description

Psoriasis is a common inflammatory disorder of the skin and in some patients the joints. Several reports have demonstrated a possible association between psoriasis and diabetes mellitus, obesity, hypertension, myocardial infarction, and heart failure.

Metabolic syndrome (MS) is a cluster of diabetes mellitus, hypertension, visceral obesity and hyperlipidemia and is thought to be caused by insulin resistance and the presence of a systemic inflammation which is evident by the increased level of inflammatory cytokines like TNF in this group of patients.

Non Alcoholic Fatty Liver Disease ( NAFLD) is the accumulation of fat vacuoles in the cytoplasm of hepatocytes and is believed to be the most common cause of chronic liver disease in developed countries. Currently, the metabolic syndrome has been found to be a strong predictor of NAFLD, and NAFLD is widely accepted to be the hepatic manifestation of the MS.

Since people with psoriasis have significantly higher rates of metabolic syndrome and regarding the fact that NAFLD is considered as the hepatic manifestation of MS, the purpose of this study is to determine the prevalence of NAFLD in subjects with psoriasis compared to the non -psoriatic population.

We have designed a case control study of patients who attend the dermatologic clinic at GWU with a clinical diagnosis of psoriasis. By performing a limited RUQ abdominal ultrasonography at the GWU hospital, we will be able to screen the patients with a possible diagnosis of NAFLD. Since NAFLD is a diagnosis of exclusion, those patients who have been screened positive for NAFLD, will be further evaluated for ruling out the other etiologies of fatty liver such as alcohol abuse and hepatitis.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from the Dermatology Clinic at George Washington University Hospital, Medical Faculty Associates.

Description

Inclusion Criteria:

• Adults of both sexes from dermatologic or radiologic clinics, between the age 18 and 80 years who wish to voluntarily participate in the study and who have signed a written informed consent form to participate.

Exclusion Criteria:

• Alcohol intake > 30 g/day in males and > 20 g/day in females.
• Presence of chronic liver disease.
• Presence of the hepatitis B virus surface antigen or the presence of virus hepatitis C antibodies.
• History of methotrexate, systemic corticosteroid, amiodarone, tamoxifen, estrogens, and/or nifedipine.
• Pregnancy
• Subjects with conditions or diseases hindering data collection and follow up of the study such as incapacitating diseases, cognitive deterioration, institutionalized patients.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Psoriasis group; All adult patients fulfilling inclusion criteria will be considered as cases in which psoriasis is detected and diagnosed by our principal investigator based on the clinical criteria accepted by American Academy of Dermatology. They will have an abdominal ultrasound performed by a radiologist to assess for the presence of nonalcoholic fatty liver disease. They will be referred to the research clinic to have a blood drawn.
Control group; For every case an age, sex and body mass index (BMI range - kg/m2) matched control will be selected from the same dermatologic/radiologic clinic. The controls will be invited to voluntarily participate and informed consent will be obtained for performing ultrasonography and analytical tests to ensure the absence of manifest hepatic disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the prevalence of NAFLD in psoriasis patients as compared to controls, via hepatic ultrasonography.	After obtaining consent

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate for the presence of other components of the metabolic syndrome in the case and control group by measuring fasting blood glucose, blood pressure, waist circumference, and a lipid profile.	After consent is obtained
Identify a possible association between extent and severity of psoriasis, and the presence of NAFLD.	After consent is obtained

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Alison Ehrlich, MD, MHS, GWU; Study Chair: Nadia Khati, MD, GWU; Study Chair: Monica Rengifo-Pardo, George Washington University

Publications and helpful links

General Publications

• Awosika O, Eleryan MG, Rengifo-Pardo M, Doherty L, Martin LW, Ehrlich A. A Case-control Study to Evaluate the Prevalence of Nonalcoholic Fatty Liver Disease Among Patients with Moderate-to-severe Psoriasis. J Clin Aesthet Dermatol. 2018 Jun;11(6):33-37. Epub 2018 Jun 1.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 29, 2009
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (Estimate): June 30, 2009

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: fatty liver; metabolic syndrome; psoriasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Skin Diseases, Papulosquamous; Liver Diseases; Fatty Liver; Psoriasis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: IRB# 030940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES