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Withdrawn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
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
Inclusion Criteria:
- Cardiology patient
- Age above 18
Exclusion Criteria:
- Age below 18
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00375349
First Posted
September 11, 2006
Last Updated
September 29, 2016
Sponsor
Shaare Zedek Medical Center
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Withdrawn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
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Non Alcoholic Fatty Liver Disease Influence of Statin Therapy
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