Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity
Overview[ - collapse ][ - ]
| Purpose | This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity. |
|---|---|
| Condition | Obesity |
| Intervention | Drug: Metformin |
| Phase | Phase 4 |
| Sponsor | University Hospital, Ghent |
| Responsible Party | University Hospital, Ghent |
| ClinicalTrials.gov Identifier | NCT00134303 |
| First Received | August 23, 2005 |
| Last Updated | January 29, 2013 |
| Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 23, 2005 |
|---|---|
| Last Updated Date | January 29, 2013 |
| Start Date | June 2005 |
| Estimated Primary Completion Date | July 2013 |
| Current 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] |
| Current 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] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity |
|---|---|
| Official Title | Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity |
| Brief Summary | This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity. |
| 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 |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Obesity |
| Intervention | Drug: Metformin Metformin is used. |
| Study Arm (s) | Experimental: NASH |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 200 |
| Estimated Completion Date | July 2013 |
| Estimated Primary Completion Date | July 2013 |
| Eligibility 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.) |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Hans Van Vlierberghe, MD, PhD +32 9 332.23.70 hans.vanvlierberghe@UGent.be |
| Location Countries | Belgium |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00134303 |
|---|---|
| Other Study ID Numbers | 2005/045 |
| Has Data Monitoring Committee | No |
| Information Provided By | University Hospital, Ghent |
| Study Sponsor | University Hospital, Ghent |
| Collaborators | Merck Sharp & Dohme Corp. |
| Investigators | Principal Investigator: Hans Van Vlierberghe, MD, PhD University Hospital, Ghent |
| Verification Date | January 2013 |
Locations[ + expand ][ + ]
| University Hospital Ghent | Ghent, Belgium, 9000 Contact: Hans Van Vlierberghe, MD, PhD | + 32 9 332.23.70 | hans.vanvlierberghe@UGent.beRecruiting |
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