Clinical Trial: Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Hyperinsulinemia and Insulin Resistance in Nonalcoholic Fatty Liver Disease. Metformin for the Treatment of Nonalcoholic Fatty Liver Disease:

Brief Summary: The purpose of this study is to find out if Metformin is safe and useful in the treatment of NAFLD.

Detailed Summary: NAFLD is a poorly understood disease which may cause an enlarged liver, abnormal liver test results, and scarring of the liver. It may occur more often in people with obesity, high levels of cholesterol (blood fats), diabetes (high blood sugar), or the insulin resistance syndrome (where a person's body does not respond to the hormone insulin which helps keep blood sugar levels normal). Currently, no effective drug treatment for NAFLD exists. There is increasing evidence that NAFLD may be a condition due to a problem with metabolism (the way your body uses energy). Previous studies have shown that high glucose (sugar) levels may play an important role in the development of fatty liver disease. Medications that decrease your natural glucose level may reduce the amount of fat in the liver and, therefore, might be useful in the treatment of NAFLD. Metformin, a drug approved by the U.S. Food and Drug Administration (FDA) for use in patients with diabetes, has been shown to improve fatty liver in animals and in a small number of human beings.
Sponsor: Manal Abdelmalek

Current Primary Outcome: Study Endpoints Will Include Measurements of Insulin Sensitivity, Hepatic Insulin Clearance, and Altered Parameters of Lipid Metabolism, Changes in the Histological Features That Define NAFLD, and Quantitative Measurements of Visceral and Peripheral Fat. [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR (Insulin Resistance) With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD. [ Time Frame: 24 months ]
  • Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo. [ Time Frame: 24 months ]
  • Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress [ Time Frame: 24 months ]


Original Secondary Outcome:

  • Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD. [ Time Frame: 24 months ]
  • Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo. [ Time Frame: 24 months ]
  • Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress [ Time Frame: 24 months ]


Information By: Duke University

Dates:
Date Received: August 13, 2008
Date Started: April 2009
Date Completion:
Last Updated: December 5, 2016
Last Verified: December 2016