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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Manal Abdelmalek, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00736385
First received: August 13, 2008
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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: April 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Metformin
 Drug: Glucophage (Metformin)
metformin XR 2000 mg daily for 12 months
Other Names:
  • metformin
  • Glucophage XR
  • Glumetza
  • Fortamet
  • Riomet
Placebo Comparator: 2
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736385

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Manal Abdelmalek
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: Manal Abdelmalek, Associate Professor of Medicine, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00736385     History of Changes
Other Study ID Numbers: Pro00006196, K23 DK062116
Study First Received: August 13, 2008
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
nonalcoholic fatty liver disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013