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
Recruitment status was Active, not recruiting
Sponsor:
University Hospital, Aker
Collaborator:
Merck
Information provided by:
University Hospital, Aker
ClinicalTrials.gov Identifier:
NCT00303537
First received: March 16, 2006
Last updated: June 29, 2007
Last verified: June 2007
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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 |
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
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 May 16, 2013