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Metformin in Non-Alcoholic Fatty Liver Disease

NCT ID: NCT00303537

Last Updated: 2007-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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metformin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University Hospital, Aker

OTHER

Sponsor Role lead

Principal Investigators

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Kaare Birkeland, Prof./Ph.D

Role: STUDY_CHAIR

Aker University Hospital, Oslo, Norway

Zbigniew Konopski, Cons./Ph.D

Role: STUDY_CHAIR

Aker University Hospital, Oslo, Norway

Kristian Bjøro, Cons./Ph.D

Role: STUDY_CHAIR

Rikshospitalet-Radiumhospitalet, Oslo, Norway

John W Haukeland, Physician

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Aker

Locations

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Haukeland Universitetssykehus

Bergen, , Norway

Site Status

Aker University Hospital

Oslo, , Norway

Site Status

Akershus University Hospital

Oslo, , Norway

Site Status

Universitetssykehuset i Nord-Norge

Tromsø, , Norway

Site Status

Countries

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Norway

References

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Haukeland JW, Dahl TB, Yndestad A, Gladhaug IP, Loberg EM, Haaland T, Konopski Z, Wium C, Aasheim ET, Johansen OE, Aukrust P, Halvorsen B, Birkeland KI. Fetuin A in nonalcoholic fatty liver disease: in vivo and in vitro studies. Eur J Endocrinol. 2012 Mar;166(3):503-10. doi: 10.1530/EJE-11-0864. Epub 2011 Dec 14.

Reference Type DERIVED
PMID: 22170794 (View on PubMed)

Haukeland JW, Konopski Z, Eggesbo HB, von Volkmann HL, Raschpichler G, Bjoro K, Haaland T, Loberg EM, Birkeland K. Metformin in patients with non-alcoholic fatty liver disease: a randomized, controlled trial. Scand J Gastroenterol. 2009;44(7):853-60. doi: 10.1080/00365520902845268.

Reference Type DERIVED
PMID: 19811343 (View on PubMed)

Other Identifiers

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AkerU3

Identifier Type: -

Identifier Source: org_study_id