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
  Purpose

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


Condition Intervention Phase
Obesity
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 2013
Estimated Primary Completion Date: July 2013 (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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00134303

Contacts
Contact: Hans Van Vlierberghe, MD, PhD +32 9 332.23.70 hans.vanvlierberghe@UGent.be

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

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00134303     History of Changes
Other Study ID Numbers: 2005/045
Study First Received: August 23, 2005
Last Updated: January 29, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Obesity
Fatty Liver
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Liver Diseases
Digestive System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014