Clinical trial: pilot study of metformin for the treatment of non‐alcoholic steatohepatitis
Summary Background Non‐alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that insulin sensitizing agents such as metformin may be beneficial for NASH. Aim To assess the effects of metformin on insulin s...
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Published in | Alimentary pharmacology & therapeutics Vol. 29; no. 2; pp. 172 - 182 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Oxford, UK
Blackwell Publishing Ltd
01.01.2009
Blackwell |
Subjects | |
Online Access | Get full text |
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Abstract | Summary
Background Non‐alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that insulin sensitizing agents such as metformin may be beneficial for NASH.
Aim To assess the effects of metformin on insulin sensitivity, body composition, serum alanine aminotransferase (ALT) levels and liver histology in patients with NASH.
Methods Patients underwent liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint was a three‐point improvement in the histological NASH activity index.
Results Of 28 patients enrolled, 26 (13 females; average age 44 years) completed 48 weeks of treatment and underwent repeat metabolic studies, imaging and liver biopsy. Thirty per cent achieved a histological response. Most patients lost weight, the average being 6 kg. There was a marked association between weight loss and improvements in NASH activity index and ALT levels (both, P < 0.01). Insulin sensitivity also improved, but the degree of change did not correlate with histological improvement.
Conclusion Metformin leads to improvements in liver histology and ALT levels in 30% of patients with NASH, probably by its effects in causing weight loss. |
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AbstractList | Background
Non‐alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that insulin sensitizing agents such as metformin may be beneficial for NASH.
Aim
To assess the effects of metformin on insulin sensitivity, body composition, serum alanine aminotransferase (ALT) levels and liver histology in patients with NASH.
Methods
Patients underwent liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint was a three‐point improvement in the histological NASH activity index.
Results
Of 28 patients enrolled, 26 (13 females; average age 44 years) completed 48 weeks of treatment and underwent repeat metabolic studies, imaging and liver biopsy. Thirty per cent achieved a histological response. Most patients lost weight, the average being 6 kg. There was a marked association between weight loss and improvements in NASH activity index and ALT levels (both,
P
< 0.01). Insulin sensitivity also improved, but the degree of change did not correlate with histological improvement.
Conclusion
Metformin leads to improvements in liver histology and ALT levels in 30% of patients with NASH, probably by its effects in causing weight loss. Summary Background Non‐alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that insulin sensitizing agents such as metformin may be beneficial for NASH. Aim To assess the effects of metformin on insulin sensitivity, body composition, serum alanine aminotransferase (ALT) levels and liver histology in patients with NASH. Methods Patients underwent liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint was a three‐point improvement in the histological NASH activity index. Results Of 28 patients enrolled, 26 (13 females; average age 44 years) completed 48 weeks of treatment and underwent repeat metabolic studies, imaging and liver biopsy. Thirty per cent achieved a histological response. Most patients lost weight, the average being 6 kg. There was a marked association between weight loss and improvements in NASH activity index and ALT levels (both, P < 0.01). Insulin sensitivity also improved, but the degree of change did not correlate with histological improvement. Conclusion Metformin leads to improvements in liver histology and ALT levels in 30% of patients with NASH, probably by its effects in causing weight loss. Non-alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that insulin sensitizing agents such as metformin may be beneficial for NASH. To assess the effects of metformin on insulin sensitivity, body composition, serum alanine aminotransferase (ALT) levels and liver histology in patients with NASH. Patients underwent liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint was a three-point improvement in the histological NASH activity index. Of 28 patients enrolled, 26 (13 females; average age 44 years) completed 48 weeks of treatment and underwent repeat metabolic studies, imaging and liver biopsy. Thirty per cent achieved a histological response. Most patients lost weight, the average being 6 kg. There was a marked association between weight loss and improvements in NASH activity index and ALT levels (both, P < 0.01). Insulin sensitivity also improved, but the degree of change did not correlate with histological improvement. Metformin leads to improvements in liver histology and ALT levels in 30% of patients with NASH, probably by its effects in causing weight loss. Non-alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that insulin sensitizing agents such as metformin may be beneficial for NASH.BACKGROUNDNon-alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that insulin sensitizing agents such as metformin may be beneficial for NASH.To assess the effects of metformin on insulin sensitivity, body composition, serum alanine aminotransferase (ALT) levels and liver histology in patients with NASH.AIMTo assess the effects of metformin on insulin sensitivity, body composition, serum alanine aminotransferase (ALT) levels and liver histology in patients with NASH.Patients underwent liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint was a three-point improvement in the histological NASH activity index.METHODSPatients underwent liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint was a three-point improvement in the histological NASH activity index.Of 28 patients enrolled, 26 (13 females; average age 44 years) completed 48 weeks of treatment and underwent repeat metabolic studies, imaging and liver biopsy. Thirty per cent achieved a histological response. Most patients lost weight, the average being 6 kg. There was a marked association between weight loss and improvements in NASH activity index and ALT levels (both, P < 0.01). Insulin sensitivity also improved, but the degree of change did not correlate with histological improvement.RESULTSOf 28 patients enrolled, 26 (13 females; average age 44 years) completed 48 weeks of treatment and underwent repeat metabolic studies, imaging and liver biopsy. Thirty per cent achieved a histological response. Most patients lost weight, the average being 6 kg. There was a marked association between weight loss and improvements in NASH activity index and ALT levels (both, P < 0.01). Insulin sensitivity also improved, but the degree of change did not correlate with histological improvement.Metformin leads to improvements in liver histology and ALT levels in 30% of patients with NASH, probably by its effects in causing weight loss.CONCLUSIONMetformin leads to improvements in liver histology and ALT levels in 30% of patients with NASH, probably by its effects in causing weight loss. |
Author | LOOMBA, R. LIANG, T. J. MODI, A. SUMNER, A. E. NAGABHYRU, P. HOOFNAGLE, J. H. LUTCHMAN, G. KLEINER, D. E. BORG, B. B. RICKS, M. FELD, J. J. |
AuthorAffiliation | Clinical Endocrinology Branch, NIDDK, National Institutes of Health (NIH), Bethesda, MD, USA Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Bethesda, MD, USA Laboratory of Pathology, National Cancer Institute, Bethesda, MD, USA |
AuthorAffiliation_xml | – name: Laboratory of Pathology, National Cancer Institute, Bethesda, MD, USA – name: Clinical Endocrinology Branch, NIDDK, National Institutes of Health (NIH), Bethesda, MD, USA – name: Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Bethesda, MD, USA |
Author_xml | – sequence: 1 givenname: R. surname: LOOMBA fullname: LOOMBA, R. – sequence: 2 givenname: G. surname: LUTCHMAN fullname: LUTCHMAN, G. – sequence: 3 givenname: D. E. surname: KLEINER fullname: KLEINER, D. E. – sequence: 4 givenname: M. surname: RICKS fullname: RICKS, M. – sequence: 5 givenname: J. J. surname: FELD fullname: FELD, J. J. – sequence: 6 givenname: B. B. surname: BORG fullname: BORG, B. B. – sequence: 7 givenname: A. surname: MODI fullname: MODI, A. – sequence: 8 givenname: P. surname: NAGABHYRU fullname: NAGABHYRU, P. – sequence: 9 givenname: A. E. surname: SUMNER fullname: SUMNER, A. E. – sequence: 10 givenname: T. J. surname: LIANG fullname: LIANG, T. J. – sequence: 11 givenname: J. H. surname: HOOFNAGLE fullname: HOOFNAGLE, J. H. |
BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20952620$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/18945255$$D View this record in MEDLINE/PubMed |
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Keywords | Human Hypoglycemic agent Biguanides Treatment Non alcoholic steatohepatitis Digestive diseases Hepatic disease Clinical trial Metformin |
Language | English |
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Background Non‐alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance,... Background Non‐alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which... Non-alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that... |
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SubjectTerms | Adult Biological and medical sciences Biopsy Digestive system Fatty Liver - drug therapy Female Gastroenterology. Liver. Pancreas. Abdomen Humans Hypoglycemic Agents - therapeutic use Liver - drug effects Liver. Biliary tract. Portal circulation. Exocrine pancreas Male Medical sciences Metformin - therapeutic use Middle Aged Other diseases. Semiology Pharmacology. Drug treatments Pilot Projects Statistics as Topic Treatment Outcome |
Title | Clinical trial: pilot study of metformin for the treatment of non‐alcoholic steatohepatitis |
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