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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00134303
First received: August 23, 2005
Last updated: January 29, 2013
Last verified: January 2013

August 23, 2005
January 29, 2013
June 2005
July 2013   (final data collection date for primary outcome measure)
Number of patients with histological amelioration of NASH after a period of 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Number of patients with histological amelioration of NASH after a period of 1 year
Complete list of historical versions of study NCT00134303 on ClinicalTrials.gov Archive Site
Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year
Not Provided
Not Provided
 
Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity
Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
Drug: Metformin
Metformin is used.
Experimental: NASH
Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2013
July 2013   (final data collection date for primary outcome measure)

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.)
Both
Not Provided
No
Contact: Hans Van Vlierberghe, MD, PhD +32 9 332.23.70 hans.vanvlierberghe@UGent.be
Belgium
 
NCT00134303
2005/045
No
University Hospital, Ghent
University Hospital, Ghent
Merck Sharp & Dohme Corp.
Principal Investigator: Hans Van Vlierberghe, MD, PhD University Hospital, Ghent
University Hospital, Ghent
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP