Obesity
Conditions
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.
Interventions
DRUGMetformin
Metformin is used.
Sponsors
Merck Sharp & Dohme LLC
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with histological amelioration of NASH after a period of 1 year | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year | 1 year |
Countries
Belgium
Outcome results
None listed