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

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

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.
Condition	Liver Diseases
Intervention	Drug: Metformin
Phase	N/A
Sponsor	Kaplan Medical Center
Responsible Party	Kaplan Medical Center
ClinicalTrials.gov Identifier	NCT00247117
First Received	October 31, 2005
Last Updated	October 6, 2006
Last verified	October 2003

Tracking Information[ + expand ][ + ]

First Received Date	October 31, 2005
Last Updated Date	October 6, 2006
Start Date	January 2004
Estimated Primary Completion Date	August 2005
Current Primary Outcome Measures	histological and biochemical changes
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
Official Title	Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease
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 7% during study will be withdrawn.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.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Liver Diseases
Intervention	Drug: Metformin
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	15
Estimated Completion Date	August 2005
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Hila Knobler, MD 08-9441650 knobler@inter.net.il
Location Countries	Israel

Administrative Information[ + expand ][ + ]

NCT Number	NCT00247117
Other Study ID Numbers	037-2003
Has Data Monitoring Committee	Not Provided
Information Provided By	Kaplan Medical Center
Study Sponsor	Kaplan Medical Center
Collaborators	Not Provided
Investigators	Study Director: Stephen D Malnick, MD Kaplan Medical Center
Verification Date	October 2003

Locations[ + expand ][ + ]