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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00134303

2005/045

Details and patient eligibility

About

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

Full description

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.

Enrollment: 65 patients

Sex: All

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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65 participants in 1 patient group

NASH

Experimental group

Treatment:

Drug: Metformin