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

Tracking Information

First Received Date ^ICMJE

August 13, 2008

Last Updated Date

December 5, 2012

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00736385 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Fatty Liver

Intervention ^ICMJE

Drug: Glucophage (Metformin)
metformin XR 2000 mg daily for 12 months
Other Names:
- metformin
- Glucophage XR
- Glumetza
- Fortamet
- Riomet
Drug: Placebo
placebo 2000 mg daily for 12 months

Study Arm (s)

Active Comparator: 1
Metformin

Intervention: Drug: Glucophage (Metformin)
Placebo Comparator: 2
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00736385

Other Study ID Numbers ^ICMJE

Pro00006196, K23 DK062116

Has Data Monitoring Committee

Responsible Party

Manal Abdelmalek, Duke University Medical Center

Study Sponsor ^ICMJE

Manal Abdelmalek

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Manal F Abdelmalek, MD, MPH

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

Information Provided By

Duke University

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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