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

NCT ID: NCT00736385

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-12-31

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.

Conditions

Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metformin

Metformin XR (extended-release) 2000 mg daily

Group Type: ACTIVE_COMPARATOR

Glucophage (Metformin)

Intervention Type: DRUG

metformin XR 2000 mg daily for 12 months

Placebo

Placebo capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo 2000 mg daily for 12 months

Interventions

Glucophage (Metformin)

metformin XR 2000 mg daily for 12 months

Intervention Type: DRUG

Placebo

placebo 2000 mg daily for 12 months

Intervention Type: DRUG

Other Intervention Names

metformin; Glucophage XR (extended-release); Glumetza; Fortamet; Riomet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manal F Abdelmalek, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Department of Medicine, Division of Gastroenterology

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

K23DK062116

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00006196

Identifier Type: -

Identifier Source: org_study_id