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NCT00134303 Clinical Trial

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

Obesity Clinical Trial

Official title:
Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00134303
Other study ID # 2005/045
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2005
Est. completion date March 31, 2006

Study information
Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date March 31, 2006
Est. primary completion date March 31, 2006
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin
Metformin is used.

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with histological amelioration of NASH after a period of 1 year 1 year
Secondary Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year 1 year
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