Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation, and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with a particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fat and fibrosis in post-menopausal women with NASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
The patch will provide 100mcg of estradiol daily.
Placebo patch will contain no estradiol.
Massachusetts General Hospital
Boston, Massachusetts, United States
Hepatic fat
Change in percentage of hepatic fat
Time frame: 12 months
Hepatic fibrosis
Decrease in hepatic fibrosis by ≥1 stage
Time frame: 12 months
Non-alcoholic fatty liver disease activity score
Change in non-alcoholic fatty liver disease activity score (minimum value: 0; maximum value: 8; lower scores indicate less disease activity) without progression of fibrosis stage
Time frame: 12 months
Whole liver transcriptome profile
Change in whole liver transcriptome profile
Time frame: 12 months
Intrahepatic immune cell profiles
Change in intrahepatic immune cell profile
Time frame: 12 months
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