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

Phase 4

Completed

• Conditions: Obesity
• Interventions: Drug: Metformin

• Registration Number: NCT00134303
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Primary Completion: 2006-03-31
• Study Completion: 2006-03-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Patients receiving bariatric surgery for obesity

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NASH	Metformin	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium