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

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: NCT00736385
Recruitment Status : Terminated
First Posted : August 15, 2008
Results First Posted : March 26, 2015
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):
Manal Abdelmalek, Duke University

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

Condition or disease Intervention/treatment Phase
Fatty Liver Drug: Glucophage (Metformin) Drug: Placebo Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperinsulinemia and Insulin Resistance in Nonalcoholic Fatty Liver Disease. Metformin for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blinded, Placebo-Controlled Trial
Study Start Date : April 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Active Comparator: Metformin
Metformin XR (extended-release) 2000 mg daily
Drug: Glucophage (Metformin)
metformin XR 2000 mg daily for 12 months
Other Names:
  • metformin
  • Glucophage XR (extended-release)
  • Glumetza
  • Fortamet
  • Riomet

Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo
placebo 2000 mg daily for 12 months

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo. [ Time Frame: 24 months ]
  3. 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 from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • biopsy-proven NAFLD, determined within 12 months of study initiation

Exclusion Criteria:

  • > 20 grams of alcohol/day
  • impaired oral glucose tolerance test
  • known diagnosis of diabetes mellitus
  • hepatitis C infection
  • cirrhosis

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): NCT00736385

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Manal Abdelmalek
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Principal Investigator: Manal F Abdelmalek, MD, MPH Duke University Medical Center, Department of Medicine, Division of Gastroenterology
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Responsible Party: Manal Abdelmalek, Associate Professor of Medicine, Duke University Identifier: NCT00736385    
Other Study ID Numbers: Pro00006196
K23DK062116 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2008    Key Record Dates
Results First Posted: March 26, 2015
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Manal Abdelmalek, Duke University:
nonalcoholic fatty liver disease
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