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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by George Washington University
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT00930384
First received: June 29, 2009
Last updated: April 25, 2014
Last verified: April 2014

June 29, 2009
April 25, 2014
November 2009
July 2014   (final data collection date for primary outcome measure)
Determine the prevalence of NAFLD in psoriasis patients as compared to controls, via hepatic ultrasonography. [ Time Frame: After obtaining consent ] [ Designated as safety issue: No ]
Hepatic ultrasonography- NAFLD [ Time Frame: After obtaining consent ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00930384 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: After consent is obtained ] [ Designated as safety issue: No ]
  • Identify a possible association between extent and severity of psoriasis, and the presence of NAFLD. [ Time Frame: After consent is obtained ] [ Designated as safety issue: No ]
Blood test - total cholesterol, HDL, LDL - fasting blood sugar - HBs Ag, Anti-HBs, Anti-HBc (total and IgM), HBe Ag, Anti-HBe, Anti HAV (total and IgM), and Anti-HCV [ Time Frame: After consent is obtained ] [ Designated as safety issue: No ]
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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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

  • Psoriasis
  • Nonalcoholic Fatty Liver Disease
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
370
June 2016
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact: Sirlekar Bullocks 202-741-6141 sbullocks@mfa.gwu.edu
United States
 
NCT00930384
IRB# 030940
No
George Washington University
George Washington University
Not Provided
Principal Investigator: Alison Ehrlich, MD, MHS GWU
Study Chair: Michael C Hill, MD GWU
Study Chair: Jack Short, MD George Washington University
George Washington University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP