Clinical trial NCT00930384: A Case Control Study Evaluating the Prevalence of Non-Alcoholic Fatty Liver Disease Among Patients With Psoriasis
Official title: A Case Control Study to Evaluate the Prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) Among Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Nonalcoholic Fatty Liver Disease
Keywords: psoriasis
fatty liver
metabolic syndrome
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from the Dermatology Clinic at George Washington University Hospital, Medical Faculty Associates.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the prevalence of NAFLD in psoriasis patients as compared to controls, via hepatic ultrasonography.
timeFrame: After obtaining consent
Secondary outcomes:
measure: 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.
timeFrame: After consent is obtained
measure: Identify a possible association between extent and severity of psoriasis, and the presence of NAFLD.
timeFrame: After consent is obtained
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Department of Dermatology
state: District of Columbia
Study officials:
affiliation: GWU
name: Alison Ehrlich, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: GWU
name: Nadia Khati, MD
role: STUDY_CHAIR
affiliation: George Washington University
name: Monica Rengifo-Pardo
role: STUDY_CHAIR
References:
citation: 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.