Where to Find NAFLD & NASH Clinical Trials
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While doctors typically recommend eating a healthy diet, exercising, and losing weight to help control Non-Alcoholic Fatty Liver Disease (NAFLD) and the more serious Non-Alcoholic Steatohepatitis (NASH), there is still a lot that we don’t know about general hepatology, these diseases, how they progress, and how we can treat them.
If you have NAFLD or NASH, you may want to consider joining a clinical trial to help doctors and researchers find solutions for you and thousands of others with these conditions. In this article, you can find the basics about what science knows about NAFLD and NASH, and where you can sign up for relevant clinical trials.
What are NAFLD & NASH?
Simply put, nonalcoholic fatty liver disease (NAFLD) is an abnormal buildup of fat in the liver. Scientists and doctors are still not entirely sure why the liver starts to store more fat, though it is related to obesity, high blood pressure, high cholesterol, type 2 diabetes, insulin resistance, hypertension and metabolic syndrome. Certain medicines, infections, and rapid weight loss can also be a cause. As the name implies, these diseases are not caused by alcohol use. Alcoholics often develop a different type of fatty liver disease.
Regardless of the cause, NAFLD is divided into two categories. There is simple fatty liver disease and the more serious nonalcoholic steatohepatitis (NASH). Steatosis is a term that describes a fatty buildup, whereas hepatitis describes inflammation of the liver (hepatic refers to the liver). While both of these diseases have few to no symptoms, NASH can result in cirrhosis (a.k.a. liver scarring or fibrosis). Unlike simple fatty liver, NASH can result in scarring because it produces a significant amount of inflammation in the liver. This inflammation can damage liver tissue and lead to scarring if the liver starts ballooning up.
This fibrosis stage can be very harmful in not treated early. NASH can even lead to hepatocellular carcinoma, a type of cancer that starts in your liver and can require surgery or a liver transplant. So, be sure to consult your doctor first. If they think it is appropriate, you may want to consider joining a clinical trial.
Why Do People Join NAFLD & NASH Clinical Trials?
There are many good reasons to join a NAFLD or NASH Clinical Trial. Clinical trials represent the final step in the process of discovering new medicines and treatments for diseases. By the time a medical intervention has reached the clinical trial phase, it has already been in development for a long time. By joining the clinical trial phase, you can help researchers better understand how to use the intervention safely and effectively.
One misconception about clinical studies is that you will get access to the newest and best medical interventions. This is not always the case. To ensure that the full benefit of the new medicine or intervention is measured, most clinical trials involve the use of a placebo. A placebo is a non-active replacement for the medicine or treatment that is used to establish the outcomes if a medicine is not administered. While clinical trials for more serious conditions (like cancer or NASH) may use the standard treatment instead of a placebo to ensure that patients are still getting appropriate care.
Researchers typically do not know who is on a placebo and who is on the intervention being testing in a situation known as “double-blind.” Since no one knows which patients received the placebo until the primary endpoint of the clinical study, when the results are statistically analyzed. By proving the effectiveness of a treatment using a double-blind placebo study, researchers can get approval from the Food and Drug Administration (FDA) to market their product or method to the general public.
Besides the benefits of helping humanity battle NAFLD and NASH, there are also some other benefits to joining a clinical trial. Typically, the treatments provided in clinical research are free of charge and you may be reimbursed for other expenses you incur traveling to or from the research site. Plus, some clinical trials may allow you to get a free liver biopsy to fully diagnose your NAFLD or blood serum tests for biomarkers that may help your doctor diagnose and treat your disease.
So, if you think joining a clinical research study is right for you, check out the sites below where you can find a clinical trial being conducted in your area.
Where to Find NAFLD & NASH Studies
There are several steps involved in finding and gaining enrollment in a clinical trial. First off, you must find a clinical trial. Below are several helpful websites that compile and organize clinical trials for the treatment of NASH and NAFLD in the United States:
- National Institute of Diabetes and Digestive and Kidney Diseases - this link will take you to ClinicalTrials.gov, which can search for several clinical trials being organized by the NIDDK and National Institutes of Health (NIH).
- TrialSpark - TrialSpark can link you to both private and public clinical trials. You can start your search by filling out an application.
- Antidote.Me - Similar to TrialSpark, Antidote.me matches patients to both government and private healthcare studies.
You can begin applying to one website, or search through all three websites for the best results. The applications will ask you about your gastroenterology health history, including if you have NAFLD or NASH and if you have experienced symptoms of pre-diabetes, liver fat buildup, or a recent worsening of fibrosis. They may also ask you about any other risk-factors you may have that may preclude you from joining in the study.
Answering these questions accurately will help determine if you are an appropriate candidate. Different clinical trials are looking for patients with nonalcoholic steatohepatitis in different stages, including NASH patients with liver fibroses or cirrhosis, and those who have more mild simple fatty liver condition. So, simply answer the questions accurately and these sites will place you connect you with the appropriate clinical trial.
Keep These Things in Mind…
- Each clinical trial is it’s own scientific experiment. It is up to the primary researchers to develop the protocol, which must then be approved by an Institutional Research Board (IRB). There are many different types of experiment and clinical data that researchers are looking for, so be sure to read the fine print to understand what you are getting into.
- There are many clinical trials for various drugs, in various stages of development. For example, one NASH drug “elafibranor” is in Phase 3 clinical trials, meaning it is very close to being approved. Other drugs (such as cenicriviroc) are still in earlier phases of the clinical research process. Yet some, like obeticholic acid, have already been approved but may be a part of a clinical trial for another drug. So, it is important to talk to your doctor and the researchers involved in the project to fully understand what you might be getting.
- Always remember that you can leave a clinical trial at any time, for any reason. You are not bound to complete the trial, though it does help researchers if volunteers are able to stay until the end.
Citations and Useful Information
Below are some excellent resources for finding out even more about NAFLD and NASH:
National Institute of Diabetes and Digestive and Kidney Diseases - NAFLD & NASH Page
Stanford Health Care - Nonalcoholic Steatohepatitis (NASH)
Medline Plus - Fatty Liver Disease (Alcoholic and Non-alcoholic)
Johns Hopkins Medicine - Nonalcoholic Fatty Liver Disease