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Metformin in Non-Alcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital, Aker

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

Condition or disease Intervention/treatment Phase
Fatty Liver Drug: metformin Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Grade of steatosis as judged by repeat biopsy [ Time Frame: 6 mo ]

Secondary Outcome Measures :
  1. Grade of necroinflammation as judged by repeat biopsy [ Time Frame: 6 mo ]
  2. Liver density obtained by computer scan [ Time Frame: 6 mo ]
  3. Serum alanine transaminase (ALAT) [ Time Frame: 6 mo ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00303537

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Haukeland Universitetssykehus
Bergen, Norway
Aker University Hospital
Oslo, Norway
Akershus University Hospital
Oslo, Norway
Universitetssykehuset i Nord-Norge
Tromsø, Norway
Sponsors and Collaborators
University Hospital, Aker
Merck Sharp & Dohme Corp.
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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00303537    
Other Study ID Numbers: AkerU3
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: July 2, 2007
Last Verified: June 2007
Keywords provided by University Hospital, Aker:
non-alcoholic fatty liver (NAFLD)
non-alcoholic steatohepatitis (NASH)
Nonalcoholic fatty liver disease
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs