NCT00303537

Metformin in Non-Alcoholic Fatty Liver Disease

Double Blind, Randomized, Placebo Controlled Trial With Metformin in Non-Alcoholic Fatty Liver Disease (NAFLD)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University Hospital, Aker · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.

Detailed description

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).

Conditions

• Fatty Liver

Interventions

Type	Name	Description
DRUG	metformin

Timeline

• Start date: 2004-11-01
• Completion: 2008-06-01
• First posted: 2006-03-17
• Last updated: 2007-07-02

Locations

4 sites across 1 country: Norway