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Novel Association of Cholesterol Ester Storage Disease Due to Lysosomal Acid Lipase Deficiency and Non-Alcoholic Fatty Liver Disease: A Prospective Clinical Study

Sponsor
Assy Nimer (Other)
Overall Status
Unknown status
CT.gov ID
NCT01791452
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is a world-wide problem with a global prevalence estimated at 1.5 billion people. It is characterised by significant diversity and phenotypic heterogeneity. Morbidity rates are estimated at 20% to 30% in Western adults, increasing to 90% in patients who are morbidly obese or diabetic. Risk factors in non-obese NAFLD patients are of especial practical and theoretical importance. Cholesterol Ester Storage Disease (CESD) is an autosomal recessive chronic disease of variable phenotype, caused by a deficiency in lysosomal acid lipase (LAL) and characterized by accumulation of fat in tissues and organs. Hepatic accumulation of fat in this disorder can cause hepatomegaly with varying degrees of damage varying from steatosis to fibrosis, elevated aminotransaminases, and isolated splenomegaly. Since the contribution of LAL deficiency to non-obese NAFLD is poorly understood, the investigators propose to evaluating the association between NAFLD and LAL deficiency in a prospective study in our population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Time Perspective:
    Prospective
    Anticipated Primary Completion Date :
    Feb 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    NAFLD

    Outcome Measures

    Primary Outcome Measures

    1. liver ultrasound, ultrasound Doppler of the common carotid artery, hepatic Fibroscan evaluation (transient elastography) for assessment of steatosis and fibrosis [year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age between 18-80 years;

    • BMI 25-40;

    • Fatty liver disease (bright liver, hepatomegaly by ultrasound (Liver span > 15 cm mid clavicle line), splenomegaly (>13 cm) or both.

    Exclusion Criteria:

    • Alcohol abuse>30 gm/day, or > 70 gram per week;

    • Soft drink abuse;

    • Drugs known to cause fatty liver;

    • Chronic hepatitis (B and C);

    • Biliary liver disease;

    • Autoimmune hepatitis;

    • HIV;

    • Genetic/Metabolic liver disease (Wilson, alpha-1 antitrypsin, CF);

    • Failure to give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assy Nimer Safed Israel 13100

    Sponsors and Collaborators

    • Assy Nimer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assy Nimer, MD, Ziv Hospital
    ClinicalTrials.gov Identifier:
    NCT01791452
    Other Study ID Numbers:
    • 0042-12-ZIV
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Feb 15, 2013
    Last Verified:
    Feb 1, 2013
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Cholesterol Ester Storage Disease

    Study Results

    No Results Posted as of Feb 15, 2013