Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134303
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2005-08-23
Brief Title:
Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis NASH Patients Receiving Bariatric Surgery for Obesity
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Brunts 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None