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Clinical Trials/NCT00930384
NCT00930384
Completed
Not Applicable

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

George Washington University1 site in 1 country150 target enrollmentNovember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psoriasis
Sponsor
George Washington University
Enrollment
150
Locations
1
Primary Endpoint
Determine the prevalence of NAFLD in psoriasis patients as compared to controls, via hepatic ultrasonography.
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
April 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: After obtaining consent

Secondary Outcomes

  • 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 Sites (1)

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