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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2003 by Kaplan Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00247117
First Posted: November 1, 2005
Last Update Posted: October 9, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaplan Medical Center
October 31, 2005
November 1, 2005
October 9, 2006
January 2004
Not Provided
histological and biochemical changes
Same as current
Complete list of historical versions of study NCT00247117 on ClinicalTrials.gov Archive Site
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Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease
The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.

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 7% during study will be withdrawn.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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Liver Diseases
Drug: Metformin
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
15
August 2005
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00247117
037-2003
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Kaplan Medical Center
Not Provided
Study Director: Stephen D Malnick, MD Kaplan Medical Center
Kaplan Medical Center
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP