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

NCT00930384 | Completed

• 1 other identifier: IRB# 030940
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Evaluate for the presence of other components metabolic syndrome in this group of patients including hypercholesterolemia, hypertension, obesity, and insulin resistance
2. 2.Determine if there is an association between the extent and severity of psoriasis and the presence of NAFLD.
3. 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.

Conditions

Psoriasis; Nonalcoholic Fatty Liver Disease

Keywords

psoriasis; fatty liver; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Determine the prevalence of NAFLD in psoriasis patients as compared to controls, via hepatic ultrasonography.

  After obtaining consent

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Department of Dermatology

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

• 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.

  PMID: 29942422 DERIVED

MeSH Terms

Conditions

Psoriasis; Non-alcoholic Fatty Liver Disease; Fatty Liver; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alison Ehrlich, MD, MHS

  GWU

  PRINCIPAL INVESTIGATOR

• Nadia Khati, MD

  GWU

  STUDY CHAIR

• Monica Rengifo-Pardo

  George Washington University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)