Status:
COMPLETED
Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Obesity
Eligibility:
All Genders
Phase:
PHASE4
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 randomi...
Eligibility Criteria
Inclusion
- Patients receiving bariatric surgery for obesity
Exclusion
- 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.)
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2006
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00134303
Start Date
June 1 2005
End Date
March 31 2006
Last Update
December 8 2022
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000