Abstract | OBJECTIVE: MATERIAL AND METHODS: Forty-eight patients with biopsy-proven NAFLD were randomized to treatment with metformin (n=24) or placebo (n=24) for 6 months. A second liver biopsy was obtained in all subjects who completed the trial (n=44). Data analyses are restricted to this group (per-protocol analyses). The primary outcome was changes in histologically assessed liver steatosis. Secondary outcomes were changes in NAFLD activity ( NAS)-score, liver steatosis assessed by computed tomography (CT), liver transaminases, body-weight, metabolic variables and inflammatory markers. RESULTS: CONCLUSIONS: Treatment with metformin for 6 months was no better than placebo in terms of improvement in liver histology in patients with NAFLD. Nevertheless, the use of metformin could still be beneficial in this group as it is associated with a reduction in serum levels of lipids and glucose. (ClinicalTrials.gov number, NCT00303537).
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Authors | John Willy Haukeland, Zbigniew Konopski, Heidi Beate Eggesbø, Hilde Løland von Volkmann, Gabriele Raschpichler, Kristian Bjøro, Terese Haaland, Else Marit Løberg, Kåre Birkeland |
Journal | Scandinavian journal of gastroenterology
(Scand J Gastroenterol)
Vol. 44
Issue 7
Pg. 853-60
( 2009)
ISSN: 1502-7708 [Electronic] England |
PMID | 19811343
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Hypoglycemic Agents
- Placebos
- Metformin
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Topics |
- Administration, Oral
- Adult
- Biopsy
- Double-Blind Method
- Enzyme-Linked Immunosorbent Assay
- Fatty Liver
(diagnostic imaging, drug therapy, pathology)
- Female
- Humans
- Hypoglycemic Agents
(administration & dosage, therapeutic use)
- Linear Models
- Liver Function Tests
- Male
- Metformin
(administration & dosage, therapeutic use)
- Middle Aged
- Placebos
- Statistics, Nonparametric
- Tomography, X-Ray Computed
- Treatment Outcome
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