Clinical trial NCT00736385: Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fatty Liver
Keywords: nonalcoholic fatty liver disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 24 months
Secondary outcomes:
measure: 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.
timeFrame: 24 months
measure: Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.
timeFrame: 24 months
measure: 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
timeFrame: 24 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Medical Center, Department of Medicine, Division of Gastroenterology
name: Manal F Abdelmalek, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: