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

University Hospital, Ghent65 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

MetforminDRUG

Metformin is used.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.)

Locations (1)

University Hospital Ghent

Ghent, Belgium

Outcomes

Primary Outcomes

Number of patients with histological amelioration of NASH after a period of 1 year

Time frame: 1 year

Secondary Outcomes

Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year

Time frame: 1 year

Data from ClinicalTrials.gov

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