Treating Nonalcoholic Steatohepatitis (NASH) With Metformin
Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
Nonalcoholic Steatohepatitis (NASH) is associated with progressive liver disease, fibrosis,
and cirrhosis. Although the cause of NASH is unknown, it is often associated with obesity,
type 2 diabetes, and insulin resistance. At present, there are no approved treatments for
NASH patients, but an experimental approach has focused on improving their insulin
sensitivity. Metformin is one of the most commonly used medications for the treatment of
diabetes.
The purpose of this study is to determine whether the medical problems of NASH patients,
specifically liver damage, improves when their insulin sensitivity is enhanced with
metformin.
The study will last 3 to 5 years and will enroll up to 30 patients. Participants will undergo
a complete medical examination, a series of lab tests, and a liver biopsy. They will then
start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage
twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to
1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will
undergo a repeat medical examination and liver biopsy.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)