The Foundation (FLF) announced today it has successfully completed participant recruitment in the SUNN study, a proof-of-concept study of screening for undiagnosed nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in a self-selected, at-risk population within non-traditional, community-based settings. SUNN study has completed recruitment of 1,006 participants across various communities in South Houston and Galveston, Texas. Full results of SUNN study are anticipated to be released in early 2020.
“Completing recruitment for this proof-of-concept study is another important step forward for FLF’s ongoing community outreach, education and advocacy efforts toward proactive screening for advancing liver disease among at-risk populations for NAFLD and NASH,” commented Wayne Eskridge, FLF’s Co-Founder and Chief Executive Officer.
An estimated 100 million Americans have NAFLD, or its more serious form NASH. Despite the significant morbidity associated with NAFLD and NASH, currently there are no global consensus guidelines to screen for liver fibrosis in at-risk individuals, including people older than 50 years with type 2 diabetes or metabolic syndrome. The medical standard of care for asymptomatic liver disease is to not actively look for the condition. As a society we do not try to screen for advancing liver disease. This practice commonly results in the first time a patient hears about NASH is being told they have cirrhosis or end stage liver disease. As a patient-led education and advocacy organization, FLF believes the current policy is incorrect.
“We believe it is just wrong to allow a patient become terminally ill before telling them about their liver disease,” said Neeraj Mistry, MD, MPH, FLF’s Chief Medical Officer. “There are no drugs to treat liver disease so doctors don’t look for it, but there are things people can do to avoid cirrhosis. Sadly, while we speak of wellness as a goal, without a pill, we don’t promote liver health.”
The SUNN study is a clinical trial sponsored by patients to develop data to argue for proactive screening for advancing liver disease. FLF aims to give visibility to, and to amplify the voices of people with NAFLD and NASH. FLF’s goal is to play a fundamental role in shaping the scientific, educational, and public health response to NAFLD and NASH by advocating and championing a patient-centric approach to improving the identification, diagnosis, treatment and support of people with NAFLD and NASH.
About NAFLD and NASH
NAFLD is rapidly being recognized as one of the most prevalent causes of chronic liver disease worldwide and the most common form of liver disease in children. NAFLD can potentially progress to cirrhosis, liver failure and liver cancer. Due to liver-related morbidity and mortality, NAFLD has major economic impact on healthcare costs. The majority of people living with NAFLD are asymptomatic and diagnosed incidentally. Currently, there are no approved treatments for NAFLD and NASH, except for lifestyle modifications.
About the SUNN Study
The SUNN study is a self-selected population study of undiagnosed NAFLD and NASH, using an Echosens FibroScan®, in at-risk populations. The primary objective is to develop evidence-based information to determine if noninvasive screening of at-risk, co-morbid people is feasible within this modality. Furthermore, a secondary objective is to educate all study participants about liver disease, lifestyle, healthy diets, organ donation, and clinical trials as part of FLF’s mission of being patient advocates. Results of the study will guide development of screening protocols to identify early stage disease in a wellness screening model.
More information about the study is available at www.clinicaltrials.gov under the study designation NCT03726827.
About Fatty Liver Foundation
The Fatty Liver Foundation is the only national, non-profit patient organization dedicated to improving the identification, diagnosis, treatment & support of Americans with fatty liver, NAFLD or NASH through awareness, screening, education and patient outreach. FLF’s goal is to improve the lives of both asymptomatic and diagnosed patients by raising awareness, developing wellness screening, educating patients and championing the development of a responsive support systems for individuals of the growing epidemic of fatty liver disease.
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