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Non Alcoholic Fatty Liver Disease Influence of Statin Therapy

Primary Purpose

Non-alcoholic Fatty Liver Disease (NAFLD)

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound to demonstrate existence of fatty liver
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Non-alcoholic Fatty Liver Disease (NAFLD) focused on measuring fatty liver, statin, non-alcoholic

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cardiology patient
  • Age above 18

Exclusion Criteria:

  • Age below 18

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 11, 2006
    Last Updated
    September 29, 2016
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00375349
    Brief Title
    Non Alcoholic Fatty Liver Disease Influence of Statin Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    Aim: To determine the prevalence of fatty liver in a cohort of patients hospitalized with chest pain in the Cardiology department. To assess the effect of statins on the prevalence of fatty liver by a cross sectional survey of patients hospitalized with chest pain.
    Detailed Description
    Consecutive patients hospitalized with chest pain will be recruited at the cardiology department. Patients with an inflammatory condition, recent infection or history of alcoholism will be excluded. After signing an informed consent each patient will undergo an ultrasound examination for diagnosis of fatty liver. Information regarding BMI, hypertension and use of medications will be collected on each patient. Blood samples for fasting glucose, hemoglobin A1C, lipid profile, ESR, and CRP and liver function tests will be collected from each participant. Prevalence of fatty liver in patients who have been taking statins for 6 months or more statins will be compared to patients who have been taking statins for a lesser period and to those who do have not taken statins using a multivariate regression analysis. Serum samples will be frozen and kept for future ongoing research.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-alcoholic Fatty Liver Disease (NAFLD)
    Keywords
    fatty liver, statin, non-alcoholic

    7. Study Design

    Study Phase
    Not Applicable
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound to demonstrate existence of fatty liver

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cardiology patient Age above 18 Exclusion Criteria: Age below 18

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16168995
    Citation
    Antonopoulos S, Mikros S, Mylonopoulou M, Kokkoris S, Giannoulis G. Rosuvastatin as a novel treatment of non-alcoholic fatty liver disease in hyperlipidemic patients. Atherosclerosis. 2006 Jan;184(1):233-4. doi: 10.1016/j.atherosclerosis.2005.08.021. Epub 2005 Oct 5. No abstract available.
    Results Reference
    background

    Learn more about this trial

    Non Alcoholic Fatty Liver Disease Influence of Statin Therapy

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