View Clinical Trial (Medical Research Study)
A Case Control Study to Evaluate the Prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) Among Patients With Psoriasis
| City: |
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Washington |
| State: |
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District of Columbia |
| Zip Code: |
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20037 |
| Conditions: |
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Psoriasis - Nonalcoholic Fatty Liver Disease |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00930384 |
| Primary Contact: |
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Principal Investigator
Alison Ehrlich, MD, MHS
GWU
Amir Zahir, MD
Phone: 202-741-2632
Email: azahir@mfa.gwu.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Washington, District of Columbia 20037
United States
Alison Ehrlich
Phone: 202-741-2619
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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