Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-03-31

Brief Summary

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This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity.

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Detailed Description

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In patients receiving bariatric surgery, a preoperative liver biopsy will confirm the presence of NASH. Those patients with NASH (histologically defined according the Brunt's criteria) will be randomized to receive metformin (2 times 850 mg orally daily) or placebo for a time period of 1 year. A control liver biopsy will be performed after one year.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NASH

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin is used.

Interventions

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Metformin

Metformin is used.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients receiving bariatric surgery for obesity

Exclusion Criteria

* Other causes of liver disease (hepatitis B virus \[HBV\], hepatitis C virus \[HCV\], primary biliary cirrhosis \[PBC\], etc.)
* Patients with diabetes type I
* Patients with endocrinological reasons for obesity (eg. Cushing, etc.)

Eligible Sex

ALL

Accepts Healthy Volunteers

No