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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00247117
• Other study ID #: 037-2003
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2005
• Last updated: October 6, 2006
• Start date: January 2004
• Est. completion date: August 2005

Study information

• Verified date: October 2003
• Source: Kaplan Medical Center
• Contact: Hila Knobler, MD
• Phone: 08-9441650
• Email: knobler[@]inter.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

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 7% during study will be withdrawn.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases

Intervention

Drug:
• Metformin

Locations

Country	Name	City	State
Israel	Institute of Endocrinology, Kaplan Medical Center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histological and biochemical changes