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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 7% during study will be withdrawn.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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00247117
Study type	Interventional
Source	Kaplan Medical Center
Contact	Hila Knobler, MD
Phone	08-9441650
Email	knobler@inter.net.il
Status	Recruiting
Phase	N/A
Start date	January 2004
Completion date	August 2005

View Details

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