Metabolic & NON-ALCOHOLIC STEATOHEPATITIS (M/NASH) STUDY
ABOUT THE STUDY
On July 11th, 2019, Gilead Sciences, Inc. and the Renown Institute for Health Innovation (IHI) announced a strategic collaboration to collect and analyze genetic and electronic health data that can enhance the understanding of a type of liver disease called Metabolic & Non-Alcoholic Steatohepatitis (M/NASH) and potentially inform development of treatment options for the disease. M/NASH impacts between 2-12% of the U.S. population and can progress to liver cirrhosis, require transplant, and risk of progression to more liver disease.
This observational study is considered a “Sub-Study” of the Healthy Nevada Project, which means that in order to qualify for this study you must be enrolled in the Healthy Nevada Project. This study utilizes genetic information obtained through the Healthy Nevada Project and information from a patient’s medical record, such as blood test or imaging test results, so this study can be possible. Some participants may be asked to provide a blood sample (Enhanced Liver Fibrosis testing) or undergo imaging tests so that more information can be gathered and used for research. The information used to create this research data is stripped of direct identifiers to ensure patient privacy and adhere to the study’s strict data policies.
At this time, existing participants in the Healthy Nevada Project who are also eligible for this study will be eligible for the Enhanced Liver Fibrosis (ELF) testing at no cost.
Participant Benefits:
- Participants will receive access to our Enhanced Liver Fibrosis (ELF) test to assess the risk of liver fibrosis or liver scarring. The test is no-cost and is the only FDA approved blood test for this condition. Results will be included in your medical record for your providers to help develop a more personalized care plan.
- Help contribute to the advancement of medicine and development of future treatment.
Qualified study participants live in northern Nevada or surrounding areas who meet at least one of the following criteria:
- Renown Patient who has enrolled or will enroll in the Healthy Nevada Project
- Type two diabetes or prediabetes
- Metabolic syndrome and dyslipidemia
- Elevated liver enzymes or elevated liver function
- High body mass index (BMI)
- Family member who has M/NASH
- High blood lipids, such as cholesterol and triglycerides
Steps to Participate
- Schedule a Virtual Consent Appointment through MyChart where a Genomic Coordinator will answer any questions, confirm your eligibility and consent you to the study.
2. Once enrolled, a Genomic Coordinator will schedule your Enhanced Liver Fibrosis (ELF) blood draw appointment.
3. Attend Lab Appointment to Complete Study Requirements.
If you have any questions about these studies, please email us at RenownIHI@renown.org or call 775-982-6914 and our research staff will assist you.
Frequently Asked Questions
Q: What is NAFLD and M/NASH?
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). M/NASH stands for Metabolic & Non-Alcoholic 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 M/NASH are often silent or non-specific, making it difficult to diagnose. About one-third of people with M/NASH develop cirrhosis or irreversible liver damage (1).
Q: How does someone get M/NASH?
A: There are a number of genes that contribute to Metabolic & Non-Alcoholic Steatohepatitis (M/NASH). If a person has family members who had or currently have M/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 M/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).
Q: How common is NAFLD and M/NASH
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 Metabolic & Non-Alcoholic Steatohepatitis (M/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).
Q: Are there treatments for NAFLD and M/NASH?
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 Metabolic & Non-Alcoholic Steatohepatitis (M/NASH) and why some people do not. There are currently no accepted FDA approved drugs to treat M/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.
Q: What can I expect if I participate in the Metabolic & Non-Alcoholic Steatohepatitis Liver Disease Genome Atlas study?
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.
Q: Is there any cost associated with being in this study?
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 Metabolic & Non-Alcoholic 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.