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Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease

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. Identifier: NCT01084486
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : March 10, 2010
Information provided by:
Wolfson Medical Center

Brief Summary:


Background: Insulin resistance has an important role in the development of nonalcoholic fatty liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a favorable effect towards hepatic steatosis and cardiovascular outcomes.

Objectives: The present study investigated the effect of metformin on arterial properties, metabolic parameters and liver function in patients with NAFLD. Methods In randomized, placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1 received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney, Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and serum adiponectin levels were determined.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease Drug: Metformin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)

Arm Intervention/treatment
Experimental: Metformin, Adiponectine, Arterial Compliance Drug: Metformin

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • In a single-center study, 63 patients (32 males and 31 females) diagnosed with nonalcoholic fatty liver disease were recruited from the outpatient clinic and evaluated for the study.

Exclusion Criteria:

  • Patients with history of unstable angina, MI, CVA or major surgery within the six months preceding entrance to the study.
  • Patients with unbalanced endocrine disease or any disease that might affect absorption of medications.
  • Patients with plasma creatinine > 1.5 mg/dl, and electrolyte abnormalities.

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 identifier (NCT number): NCT01084486

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Wolfson Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT01084486    
Other Study ID Numbers: WolfsonMC-2007-9
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: March 2010
Keywords provided by Wolfson Medical Center:
nonalcoholic fatty liver disease
Pulse wave velocity
augmentation index
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs