Treating Nonalcoholic Steatohepatitis (NASH) With Metformin

PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Hepatitis
Interventions
DRUG

Metformin

After complete medical evaluation and liver biopsy, patients who qualified for therapy were started on metformin in an initial dose of 500 mg once daily. After 2 weeks, the dose was increased to 500 mg twice daily and after 4 weeks to the full dose of 1000 mg twice daily. Subsequent dose reductions were carried out based on tolerance, with particular attention to gastrointestinal upset and abdominal bloating. Patients were seen in the out-patient clinic, had a brief medical history and examination and routine blood tests at 2 and 4 weeks after enrolment and every 4 weeks thereafter. The oral and intravenous glucose tolerance tests were repeated after 40 and 44 weeks respectively and liver biopsy and imaging tests at 48 weeks. Metformin was discontinued after 48 weeks in patients without diabetes on the pre-treatment evaluation.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

NCT00063232 - Treating Nonalcoholic Steatohepatitis (NASH) With Metformin | Biotech Hunter | Biotech Hunter