The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.
Nonalcoholic fatty liver disease (NAFLD) is a prevalent disorder associated with insulin resistance. Metformin is a drug that has been used for several decades in the treatment of diabetes mellitus. Metformin is known to improve insulin sensitivity. Some authors have reported beneficial effects of metformin in NAFLD, others have not been able to reproduce these findings. Only a few randomized controlled studies have been published so far, and there is still need for controlled trials with sufficient power to assess the efficacy of metformin in this condition. The aim of this study is to see whether treatment with metformin for 26 weeks results in reduction of liver steatosis (primary endpoint) and reduction in grade of inflammation in those with non-alcoholic steatohepatitis (NASH) (secondary endpoint).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Haukeland Universitetssykehus
Bergen, Norway
Aker University Hospital
Oslo, Norway
Akershus University Hospital
Oslo, Norway
Universitetssykehuset i Nord-Norge
Tromsø, Norway
Grade of steatosis as judged by repeat biopsy
Time frame: 6 mo
Grade of necroinflammation as judged by repeat biopsy
Time frame: 6 mo
Liver density obtained by computer scan
Time frame: 6 mo
Serum alanine transaminase (ALAT)
Time frame: 6 mo
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