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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134303
First Posted: August 24, 2005
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University Hospital, Ghent
August 23, 2005
August 24, 2005
December 5, 2014
June 2005
July 2015   (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 ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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.
 
Unknown status
200
July 2015
July 2015   (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.)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00134303
2005/045
No
Not Provided
Not Provided
University Hospital, Ghent
University Hospital, Ghent
Merck Sharp & Dohme Corp.
Principal Investigator: Hans Van Vlierberghe, MD, PhD University Hospital, Ghent
University Hospital, Ghent
December 2014

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