Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
Recruitment status was: Recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease|
- histological and biochemical changes
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||August 2005|
30 patients will be included who meet all the following criteria: ALT > 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake < 40 g/week.
All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included.
Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic > 7% during study will be withdrawn.
All patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. Patients will be receiving metformin 850 mg tid for 12 months.
- Improvement of liver enzymes (ALT, AST, GGT)
- Improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, HOMA.
- Liver histology (repeated liver biopsy after 1 year).
- Soluble TNF receptors- TNF-receptor P55 and P75.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247117
|Institute of Endocrinology, Kaplan Medical Center|
|Rehovot, Israel, 76100|
|Study Director:||Stephen D Malnick, MD||Kaplan Medical Center|