NCT00736385

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fatty Liver

Interventions

Type	Name	Description
DRUG	Glucophage (Metformin)	metformin XR 2000 mg daily for 12 months
DRUG	Placebo	placebo 2000 mg daily for 12 months

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-08-15
• Last updated: 2024-01-26
• Results posted: 2015-03-26

Locations

1 site across 1 country: United States