Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) - Full Text View

Sponsored by:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00736385

Purpose

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

Condition	Intervention	Phase
Fatty Liver	Drug: Glucophage (Metformin) Drug: Placebo	Phase IV

MedlinePlus related topics: Liver Diseases

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Duke University:

Primary Outcome Measures:

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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tests the postulate that metformin will improve insulin sensitivity in NAFLD. Also test the postulate that improving IR with an insulin sensitizing agent will improve biochemical and histological features of NAFLD. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Determine if metformin improves the altered parameters of lipid metabolism as compared to placebo. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Metformin	Drug: Glucophage (Metformin) metformin XR 2000 mg daily for 12 months
2: Placebo Comparator Placebo	Drug: Placebo placebo 2000 mg daily for 12 months

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

biopsy-proven NAFLD, determined within 6 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736385

Contacts

Contact: Dawn Piercy, MS, NP

866-704-4673

dawn.piercy@duke.edu

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Manal F Abdelmalek, MD, MPH

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

More Information

No publications provided

Responsible Party:	Duke University Medical Center, Division of Gastroenterology ( Manal F. Abdelmalek, M.D., M.P.H., Assistant Professor of Medicine )
Study ID Numbers:	Pro00006196, K23 DK062116
Study First Received:	August 13, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00736385
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

nonalcoholic fatty liver disease

Study placed in the following topic categories:

Hyperinsulinism
Liver Diseases
Non-alcoholic steatohepatitis (NASH)
Digestive System Diseases

Metformin
Fatty Liver
Insulin Resistance
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009