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

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ClinicalTrials.gov Identifier: NCT00247117
Recruitment Status : Unknown
Verified October 2003 by Kaplan Medical Center.
Recruitment status was:  Recruiting
First Posted : November 1, 2005
Last Update Posted : October 9, 2006
Sponsor:
Information provided by:
Kaplan Medical Center

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.

Condition or disease Intervention/treatment Phase
Liver Diseases Drug: Metformin Not Applicable

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 7% during study will be withdrawn.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  (Clinical Trial)
Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease
Study Start Date : January 2004
Study Completion Date : August 2005





Primary Outcome Measures :
  1. histological and biochemical changes


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247117


Contacts
Contact: Hila Knobler, MD 08-9441650 knobler@inter.net.il

Locations
Israel
Institute of Endocrinology, Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Sponsors and Collaborators
Kaplan Medical Center
Investigators
Study Director: Stephen D Malnick, MD Kaplan Medical Center

ClinicalTrials.gov Identifier: NCT00247117     History of Changes
Other Study ID Numbers: 037-2003
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: October 9, 2006
Last Verified: October 2003

Keywords provided by Kaplan Medical Center:
non-alcoholic fatty liver disease
insulin resistance
metformin

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs