Metformin in Non-Alcoholic Fatty Liver Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by University Hospital, Aker.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital, Aker
ClinicalTrials.gov Identifier:
NCT00303537
First received: March 16, 2006
Last updated: June 29, 2007
Last verified: June 2007
  Purpose

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


Condition Intervention Phase
Fatty Liver
Drug: metformin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double Blind, Randomized, Placebo Controlled Trial With Metformin in Non-Alcoholic Fatty Liver Disease (NAFLD)

Resource links provided by NLM:


Further study details as provided by University Hospital, Aker:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: November 2004
Estimated Study Completion Date: June 2008
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).

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303537

Locations
Norway
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.
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
  More Information

No publications provided by University Hospital, Aker

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00303537     History of Changes
Other Study ID Numbers: AkerU3
Study First Received: March 16, 2006
Last Updated: June 29, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by University Hospital, Aker:
hepatitis
metformin
non-alcoholic fatty liver (NAFLD)
non-alcoholic steatohepatitis (NASH)
Nonalcoholic fatty liver disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014