Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
NCT ID: NCT00247117
Last Updated: 2006-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2004-01-31
2005-08-31
Brief Summary
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Detailed Description
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30 patients will be included who meet all the following criteria: ALT \> 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake \< 40 g/week.
All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included.
Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic \> 7% during study will be withdrawn.
Intervention:
All patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. Patients will be receiving metformin 850 mg tid for 12 months.
Outcome:
* Improvement of liver enzymes (ALT, AST, GGT)
* Improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, HOMA.
* Liver histology (repeated liver biopsy after 1 year).
* Soluble TNF receptors- TNF-receptor P55 and P75.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Metformin
Eligibility Criteria
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Inclusion Criteria
* 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
* Alcohol intake \> 40 g per week.
18 Years
60 Years
ALL
No
Sponsors
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Kaplan Medical Center
OTHER
Principal Investigators
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Stephen D Malnick, MD
Role: STUDY_DIRECTOR
Kaplan Medical Center
Locations
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Institute of Endocrinology, Kaplan Medical Center
Rehovot, , Israel
Countries
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Central Contacts
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Other Identifiers
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037-2003
Identifier Type: -
Identifier Source: org_study_id