NASH STUDY

A: Nonalcoholic Fatty Liver Disease (NAFLD) is a build-up of fat in the liver of people who don’t abuse alcohol. It is normal for the liver to contain some fat, but if more than 5 percent of the liver’s weight is fat, it’s considered a fatty liver (steatosis). NASH stands for Nonalcoholic Steatohepatitis and is the most severe form of NAFLD in which you have liver cell damage and hepatitis (inflammation) of the liver.  Inflammation and liver cell damage can cause fibrosis, or scarring of the liver, and can cause decreased liver function (2).  The symptoms for NASH are often silent or non-specific, making it difficult to diagnose.  About one-third of people with NASH develop cirrhosis or irreversible liver damage (1).

A: There are a number of genes that contribute to Nonalcoholic Steatohepatitis (NASH). If a person has family members who had or currently have NASH or Nonalcoholic Fatty Liver Disease (NAFLD), they may be at risk. Additionally, having certain health conditions may increase a person’s risk to develop NASH. These include: being overweight or obese, having high cholesterol or high triglyceride levels, having type 2 diabetes, and having insulin resistance or prediabetes (3).

A: Nonalcoholic Fatty Liver Disease (NAFLD) is the most common chronic liver condition in the United States. Although the condition is thought to be under- diagnosed and estimates very, it is predicted that 1 out of 4 adults in the U.S have NAFLD. Of those with NAFLD, about 20 percent have Nonalcoholic Steatohepatitis (NASH) (2).  That equates to approximately 2-5% of adults in the U.S. or 6.5 – 16.3 million people who may have NASH (2).

A: We are asking participants to consider being a part of this study to help us learn why some people develop a type of liver disease called Nonalcoholic Steatohepatitis (NASH) and why some people do not. There are currently no accepted FDA approved drugs to treat NASH, and we need volunteers at various risk for the disease to develop new treatments. By analyzing genetic information from participation in the Healthy Nevada Project and medical record information, we hope to be able to develop new therapies and treatments for the disease.

A: If you have not participated in the Healthy Nevada Project, you will be asked to join as an inclusion criteria for participation in this study. The Healthy Nevada Project is a clinical research study that provides de-identified genetic data that can be used for research using a small saliva sample. You will be asked to go through the consent process for the Healthy Nevada Project if you are not already enrolled in the project.

As a participant in this study, you will be asked to allow us access to your medical information to be used in a de-identified data set for research and development, and associate that information with your de-identified genetic information in our joint genetic and health information database. You may be periodically contacted via email with important information, such as new research developments, surveys, insights or opportunities being offered to participants.

It is possible that you may be asked to provide a blood sample which will be used in an enhanced liver fibrosis (ELF) test or similar diagnostic test, or asked to have an imaging test performed, such as elastography or liver elastography, that checks the liver for fibrosis. Not all participants will be asked to undergo these tests, and if you are asked, they can be conducted at your convenience.

A: Participation in this research study is offered at no cost.  Participants receive no-cost genetic sequencing, ancestry, and wellness insights through the Healthy Nevada Project. As a participant in the Nonalcoholic Steatohepatitis Liver Disease Genome Atlas study, any tests requested as a component of the research study, such as blood or imaging tests, will also be provided at no cost.

If you are asked to provide a blood sample or have imaging performed, you will be provided with clinical diagnostic information from these tests. The results of the tests will be put in your medical record and will be available to your doctor to help direct your care. Visits to your doctor, whether directly or indirectly related to this study, are not covered.