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

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ClinicalTrials.gov Identifier: NCT00134303
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 24, 2005
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University Hospital, Ghent

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

Condition or disease Intervention/treatment Phase
Obesity Drug: Metformin Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity
Study Start Date : June 2005
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015


Arm Intervention/treatment
Experimental: NASH Drug: Metformin
Metformin is used.




Primary Outcome Measures :
  1. Number of patients with histological amelioration of NASH after a period of 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00134303     History of Changes
Other Study ID Numbers: 2005/045
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

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