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

Duke University

Status and phase: Terminated; Phase 4

Conditions: Fatty Liver

Treatments: Drug: Glucophage (Metformin); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00736385

K23DK062116 (U.S. NIH Grant/Contract)

Pro00006196

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups, including a placebo group

Metformin

Active Comparator group

Description:

Metformin XR (extended-release) 2000 mg daily

Treatment:

Drug: Glucophage (Metformin)

Placebo

Placebo Comparator group

Description:

Placebo capsule

Treatment:

Drug: Placebo