NCT00736385

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 26, 2015

Completed
Last Updated

January 26, 2024

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

August 13, 2008

Results QC Date

March 17, 2015

Last Update Submit

January 24, 2024

Conditions

Fatty Liver

Keywords

nonalcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 months

Secondary Outcomes (3)

  • 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.

    24 months

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

    24 months

  • 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

    24 months

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Metformin XR (extended-release) 2000 mg daily

Drug: Glucophage (Metformin)

Placebo

PLACEBO COMPARATOR

Placebo capsule

Drug: Placebo

Interventions

Glucophage (Metformin)DRUG

metformin XR 2000 mg daily for 12 months

Also known as: metformin, Glucophage XR (extended-release), Glumetza, Fortamet, Riomet
Metformin
PlaceboDRUG

placebo 2000 mg daily for 12 months

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • biopsy-proven NAFLD, determined within 12 months of study initiation

You may not qualify if:

  • \> 20 grams of alcohol/day
  • impaired oral glucose tolerance test
  • known diagnosis of diabetes mellitus
  • hepatitis C infection
  • cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver Disease

Interventions

Metformin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Limitations and Caveats

Study was terminated early due to difficulties with enrollment.

Results Point of Contact

Title
Christopher Kigongo
Organization
Duke University Medical Center
christopher.kigongo@duke.edu
919-668-6579

Study Officials

  • Manal F Abdelmalek, MD, MPH

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

April 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 26, 2024

Results First Posted

March 26, 2015

Record last verified: 2016-12

Locations

US(1)