Study of Losartan in the Treatment of NAFLD in Children
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and
is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of
mortality and natural history studies of adults show that NAFLD is an independent risk factor
for cardiovascular disease. Pediatric NAFLD is particularly concerning from a public health
standpoint, as it represents an early and possibly more aggressive form of the disease.
Currently there is no effective treatment for pediatric NAFLD.
Losartan is an orally-administered angiotensin II receptor antagonist which is currently on
the market to treat high blood pressure. The renin-angiotensin-aldosterone (RAA) system has
been shown to be important in many disease states including renal disease, cardiovascular
disease, and NAFLD. Angiotensin antagonists are a class of medications that has been proposed
as a novel treatment of NAFLD in part because they would treat both the factors increasing
cardiovascular (CVD) risks as well as potentially improve steatosis, fibrosis and hepatic
inflammation.
This study is a randomized, double-blinded, placebo-controlled pilot study to evaluate
whether 8 weeks of Losartan will decrease inflammatory markers among children ages 12-19 with
a current diagnosis of NAFLD. Efficacy will be assessed by improvement in alanine
aminotransferase (ALT) from baseline. Secondary endpoints will include aspartate
aminotransferase (AST), cytokeratin 18 levels, and fasting triglyceride levels among others.
Safety will be assessed by the recording of adverse events, clinical laboratory parameters,
vital signs and physical examinations.
Phase:
Phase 2
Details
Lead Sponsor:
Miriam Vos, MD
Collaborators:
Children's Healthcare of Atlanta National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)