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

This study is currently recruiting participants.
Verified October 2011 by George Washington University
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT00930384
First received: June 29, 2009
Last updated: March 11, 2013
Last verified: October 2011
History of Changes
  Purpose

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.

Condition
Psoriasis
Nonalcoholic Fatty Liver Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Case Control Study to Evaluate the Prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) Among Patients With Psoriasis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by George Washington University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 370
Study Start Date: November 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930384

Contacts
Contact: Amir Zahir, MD 202-741-2632 azahir@mfa.gwu.edu

Locations
United States, District of Columbia
George Washington University Department of Dermatology Recruiting
Washington, District of Columbia, United States, 20037
Contact: Alison Ehrlich     202-741-2619        
Principal Investigator: Alison Ehrlich, MD, MHS            
Sub-Investigator: Michael C Hill, MD            
Sub-Investigator: Amir Zahir, MD            
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Alison Ehrlich, MD, MHS GWU
Study Chair: Michael C Hill, MD GWU
Study Chair: Amir Zahir, MD GWU
  More Information

No publications provided

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT00930384     History of Changes
Other Study ID Numbers: IRB# 030940
Study First Received: June 29, 2009
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
psoriasis
fatty liver
metabolic syndrome

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Psoriasis
 Digestive System Diseases
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013