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 December 2014 by University Hospital, Ghent
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: August 23, 2005
Last updated: December 4, 2014
Last verified: December 2014
This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity.

Condition Intervention Phase
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Number of patients with histological amelioration of NASH after a period of 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: June 2005
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NASH Drug: Metformin
Metformin is used.

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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00134303

Contact: Hans Van Vlierberghe, MD, PhD +32 9 332.23.70

University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Hans Van Vlierberghe, MD, PhD    + 32 9 332.23.70   
Sponsors and Collaborators
University Hospital, Ghent
Merck Sharp & Dohme Corp.
Principal Investigator: Hans Van Vlierberghe, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT00134303     History of Changes
Other Study ID Numbers: 2005/045 
Study First Received: August 23, 2005
Last Updated: December 4, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Signs and Symptoms
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on April 27, 2016