Clinical trial

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

NCT00736385

Name

Pro00006196

Description

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

Trial arms

Trial start

2009-04-01

Estimated PCD

2012-12-01

Trial end

2012-12-01

Status

Terminated

Phase

Early phase I

Treatment

Glucophage (Metformin)

metformin XR 2000 mg daily for 12 months

Arms:

Metformin

Other names:

metformin, Glucophage XR (extended-release), Glumetza, Fortamet, Riomet

Placebo

placebo 2000 mg daily for 12 months

Arms:

Placebo

Size

Primary endpoint

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

Updated at

2024-01-26

1 organization

2 products

1 indication

Organization

Product

Indication

Product