Metformin in Non-Alcoholic Fatty Liver Disease
Overview[ - collapse ][ - ]
Purpose | The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease. |
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Condition | Fatty Liver |
Intervention | Drug: metformin |
Phase | Phase 2/Phase 3 |
Sponsor | University Hospital, Aker |
Responsible Party | University Hospital, Aker |
ClinicalTrials.gov Identifier | NCT00303537 |
First Received | March 16, 2006 |
Last Updated | June 29, 2007 |
Last verified | June 2007 |
Tracking Information[ + expand ][ + ]
First Received Date | March 16, 2006 |
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Last Updated Date | June 29, 2007 |
Start Date | November 2004 |
Estimated Primary Completion Date | June 2008 |
Current Primary Outcome Measures | Grade of steatosis as judged by repeat biopsy [Time Frame: 6 mo] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Metformin in Non-Alcoholic Fatty Liver Disease |
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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 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). |
Study Type | Interventional |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
Condition | Fatty Liver |
Intervention | Drug: metformin |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 90 |
Estimated Completion Date | June 2008 |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | Inclusion Criteria: - Histologically proven NAFLD less than 18 months prior to inclusion. For those with pure steatosis, ALAT or aspartate aminotransferase (ASAT) must be elevated above the upper limits of normal, and impaired glucose tolerance or diabetes mellitus type 2 must be present. - Body weight within +/- 5 kg compared with the weight at the time of biopsy. Exclusion Criteria: - Treatment for more than 1 week with metformin or glitazones the last 6 months before inclusion. - Treatment with insulin. - Hypersensitivity to metformin. - Treatment with cimetidine. - Heart failure requiring pharmacological treatment. - Coronary heart disease (New York Heart Association [NYHA] class 3 or 4). - Chronic obstructive lung disease (moderate or severe). - Breast-feeding or pregnant. - Metabolic acidosis. - Renal failure (male [♂]: creatinine > 135 micromol/L, female [♀] > 110 micromol/L). - Average alcohol consumption > 24 g/day the last year. - Serum ALAT or serum ASAT > 5 x upper limit of normal (ULN) at screening. - Cirrhosis. - Platelets < 100 000. - Haemochromatosis. - Alfa-1-antitrypsin-deficiency. - Wilson's disease. - Thyroid dysfunction (0.2 mU/L < thyroid stimulating hormone [TSH] < 5.0 mU/L). - Chronic infection with hepatitis B or C virus or HIV. - Autoimmune hepatitis (antinuclear antibodies [ANA] > 1/256 or smooth muscle antibodies [SMA] > 1/128). - Primary biliary cirrhosis (antimitochondrial antibodies [AMA] > 1/64). - Primary sclerosing cholangitis. - Previous participation in another clinical trial the last 6 months. - Legal incapability. |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Norway |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00303537 |
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Other Study ID Numbers | AkerU3 |
Has Data Monitoring Committee | No |
Information Provided By | University Hospital, Aker |
Study Sponsor | University Hospital, Aker |
Collaborators | Merck Sharp & Dohme Corp. |
Investigators | Study Chair: Kaare Birkeland, Prof./Ph.D Aker University Hospital, Oslo, NorwayStudy Chair: Zbigniew Konopski, Cons./Ph.D Aker University Hospital, Oslo, NorwayStudy Chair: Kristian Bjøro, Cons./Ph.D Rikshospitalet-Radiumhospitalet, Oslo, NorwayPrincipal Investigator: John W Haukeland, Physician University Hospital, Aker |
Verification Date | June 2007 |
Locations[ + expand ][ + ]
Haukeland Universitetssykehus | Bergen, Norway |
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Aker University Hospital | Oslo, Norway |
Akershus University Hospital | Oslo, Norway |
Universitetssykehuset i Nord-Norge | Tromsø, Norway |