Clinical Trial: Metformin in Non-Alcoholic Fatty Liver Disease
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Double Blind, Randomized, Placebo Controlled Trial With Metformin in Non-Alcoholic Fatty Liver Disease (NAFLD)
Brief Summary: The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.
Detailed Summary:
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).
Sponsor: University Hospital, Aker
Current Primary Outcome: Grade of steatosis as judged by repeat biopsy [ Time Frame: 6 mo ]
Original Primary Outcome: Grade of steatosis as judged by repeat biopsy.
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- Grade of necroinflammation as judged by repeat biopsy.
- Liver density obtained by computer scan.
- Serum ALAT.
Information By: University Hospital, Aker
Dates:
Date Received: March 16, 2006
Date Started: November 2004
Date Completion: June 2008
Last Updated: June 29, 2007
Last Verified: June 2007
