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

Primary Purpose

Fatty Liver

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glucophage (Metformin)
Placebo
Sponsored by
Manal Abdelmalek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring nonalcoholic fatty liver disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

Metformin XR (extended-release) 2000 mg daily

Placebo capsule

Outcomes

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.

Secondary Outcome Measures

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.
Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.
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

Full Information

First Posted
August 13, 2008
Last Updated
December 5, 2016
Sponsor
Manal Abdelmalek
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1. Study Identification

Unique Protocol Identification Number
NCT00736385
Brief Title
Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
Acronym
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manal Abdelmalek

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
Keywords
nonalcoholic fatty liver disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin XR (extended-release) 2000 mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Intervention Type
Drug
Intervention Name(s)
Glucophage (Metformin)
Other Intervention Name(s)
metformin, Glucophage XR (extended-release), Glumetza, Fortamet, Riomet
Intervention Description
metformin XR 2000 mg daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo 2000 mg daily for 12 months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Time Frame
24 months
Title
Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.
Time Frame
24 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal F Abdelmalek, MD, MPH
Organizational Affiliation
Duke University Medical Center, Department of Medicine, Division of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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