Metformin in Non-Alcoholic Fatty Liver Disease
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|ClinicalTrials.gov Identifier: NCT00303537|
Recruitment Status : Unknown
Verified June 2007 by University Hospital, Aker.
Recruitment status was: Active, not recruiting
First Posted : March 17, 2006
Last Update Posted : July 2, 2007
|Condition or disease||Intervention/treatment||Phase|
|Fatty Liver||Drug: metformin||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Double Blind, Randomized, Placebo Controlled Trial With Metformin in Non-Alcoholic Fatty Liver Disease (NAFLD)|
|Study Start Date :||November 2004|
|Estimated Study Completion Date :||June 2008|
U.S. FDA Resources
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303537
|Aker University Hospital|
|Akershus University Hospital|
|Universitetssykehuset i Nord-Norge|
|Study Chair:||Kaare Birkeland, Prof./Ph.D||Aker University Hospital, Oslo, Norway|
|Study Chair:||Zbigniew Konopski, Cons./Ph.D||Aker University Hospital, Oslo, Norway|
|Study Chair:||Kristian Bjøro, Cons./Ph.D||Rikshospitalet-Radiumhospitalet, Oslo, Norway|
|Principal Investigator:||John W Haukeland, Physician||University Hospital, Aker|