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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00247117 |
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Date of registration:
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31/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
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Scientific title:
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Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00247117 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Hila Knobler, MD |
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Address:
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Telephone:
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08-9441650 |
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Email:
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knobler@inter.net.il |
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Affiliation:
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Name:
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Stephen D Malnick, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kaplan Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ALT > 2 times normal range.
- Liver histology revealing non-alcoholic steatohepatitis [NASH] (type 2-4), without
cirrhosis.
- Clinical characteristics of the metabolic syndrome as defined by the National
Cholesterol Education Program (NCEP), but no overt diabetes.
- Negative work-up for other causes of liver diseases including alcohol intake < 40
g/week.
Exclusion Criteria:
- Diabetes mellitus.
- Alcohol intake > 40 g per week.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Liver Diseases
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Intervention(s)
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Drug: Metformin
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Primary Outcome(s)
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histological and biochemical changes
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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