Metformin in Non-Alcoholic Fatty Liver Disease

June 29, 2007 updated by: University Hospital, Aker

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Haukeland Universitetssykehus
      • Oslo, Norway
        • Akershus University Hospital
      • Oslo, Norway
        • Aker University Hospital
      • Tromsø, Norway
        • Universitetssykehuset i Nord-Norge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Grade of steatosis as judged by repeat biopsy
Time Frame: 6 mo
6 mo

Secondary Outcome Measures

Outcome Measure
Time Frame
Grade of necroinflammation as judged by repeat biopsy
Time Frame: 6 mo
6 mo
Liver density obtained by computer scan
Time Frame: 6 mo
6 mo
Serum alanine transaminase (ALAT)
Time Frame: 6 mo
6 mo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Aker

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria

March 16, 2006

First Posted (Estimate)

March 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 2, 2007

Last Update Submitted That Met QC Criteria

June 29, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AkerU3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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