Status:
UNKNOWN
Metformin in Non-Alcoholic Fatty Liver Disease
Lead Sponsor:
University Hospital, Aker
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Fatty Liver
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
PHASE3
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. M...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00303537
Start Date
November 1 2004
End Date
June 1 2008
Last Update
July 2 2007
Active Locations (4)
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1
Haukeland Universitetssykehus
Bergen, Norway
2
Aker University Hospital
Oslo, Norway
3
Akershus University Hospital
Oslo, Norway
4
Universitetssykehuset i Nord-Norge
Tromsø, Norway