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

Phase 4

Terminated

• Conditions: Fatty Liver
• Interventions: Drug: Glucophage (Metformin); Drug: Placebo

• Registration Number: NCT00736385
• Lead Sponsor: Duke University

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Study Start: 2009-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2015-03-17
• Results First Submitted QC: 2015-03-17
• Results First Posted: 2015-03-26
• Status Verified: 2016-12
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Glucophage (Metformin)	Metformin XR (extended-release) 2000 mg daily
Placebo	Placebo	Placebo capsule

Primary Outcome Measures

Name	Time	Method
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.	24 months

Secondary Outcome Measures

Name	Time	Method
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.	24 months
Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.	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	24 months

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States