Liver Diseases Clinical Trial
Official title:
Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease
The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.
Study population:
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during study will be withdrawn.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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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