Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00247117

Enrollment

Registered

2005-11-01

Start date

2004-01-31

Completion date

2005-08-31

Last updated

2006-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases

Keywords

non-alcoholic fatty liver disease, insulin resistance, metformin

Brief summary

The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.

Detailed description

Study population: 30 patients will be included who meet all the following criteria: ALT \> 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake \< 40 g/week. All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included. Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic \> 7% during study will be withdrawn. Intervention: All patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. Patients will be receiving metformin 850 mg tid for 12 months. Outcome: * Improvement of liver enzymes (ALT, AST, GGT) * Improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, HOMA. * Liver histology (repeated liver biopsy after 1 year). * Soluble TNF receptors- TNF-receptor P55 and P75.

Interventions

DRUGMetformin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* ALT \> 2 times normal range. * Liver histology revealing non-alcoholic steatohepatitis \[NASH\] (type 2-4), without cirrhosis. * Clinical characteristics of the metabolic syndrome as defined by the National Cholesterol Education Program (NCEP), but no overt diabetes. * Negative work-up for other causes of liver diseases including alcohol intake \< 40 g/week.

Exclusion criteria

* Diabetes mellitus. * Alcohol intake \> 40 g per week.

Design outcomes

Primary

Measure	Time frame
histological and biochemical changes	—

Countries

Israel

Contacts

Primary ContactHila Knobler, MD

knobler@inter.net.il08-9441650

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026