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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2003 by Kaplan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kaplan Medical Center
ClinicalTrials.gov Identifier:
NCT00247117
First received: October 31, 2005
Last updated: October 6, 2006
Last verified: October 2003
  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 Intervention
Liver Diseases
Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Kaplan Medical Center:

Primary Outcome Measures:
  • histological and biochemical changes

Estimated Enrollment: 15
Study Start Date: January 2004
Estimated Study Completion Date: August 2005
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 7% during study will be withdrawn.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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00247117     History of Changes
Other Study ID Numbers: 037-2003
Study First Received: October 31, 2005
Last Updated: October 6, 2006
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014