Fatty liver disease has been in the news recently with the death of singer George Michael. In March 2017, British officials released the artist's causes of death: heart disease and fatty liver disease.
As the name implies, fatty liver disease is a condition in which there’s too much fat in the liver. There are two main types of the disease. The first is alcoholic fatty liver disease, which is caused by drinking too much alcohol, even for a short period of time. The second is nonalcoholic fatty liver disease.
My colleagues and I have studied nonalcoholic fatty liver disease, but there is still much to learn. As of April 2017, we’re seeking people who have been diagnosed with the disease to enroll in a study that we hope will help us learn more about a new drug we hope will reduce the liver inflammation that leads to scarring or cirrhosis of the liver.
Though we continue to learn more about fatty liver disease through our research, we do know what factors can increase a person’s risk for the disease. Let’s discuss these risk factors, as well as the criteria for joining our clinical trial.
How common is fatty liver disease?
Fatty liver disease is one of the most common liver diseases in the United States. As noted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), between 30 and 40 percent of U.S. adults are considered obese and therefore have the potential for having nonalcoholic fatty liver disease. If we apply that to the nearly 30 million people in Texas, as many as 12 million Texans may have the disease.
Most cases of fatty liver disease don’t cause serious liver damage; about 20 percent of people with fatty liver disease develop severe enough inflammation, resulting from damage to liver cells, to lead to cirrhosis. This condition is known as nonalcoholic steatohepatitis, or NASH. The NIDDK estimates that as many as 12 percent of U.S. adults have NASH.
As the Centers for Disease Control and Prevention notes, Texas is in the top 10 states for deaths caused by cirrhosis of the liver. NASH can lead to liver cancer as well. In some cases, people with NASH may need a liver transplant.
Who is at risk for fatty liver disease?
Food connoisseurs may know that “fatty liver” translates to the French term “foie gras.” Foie gras is considered a delicacy in France and is composed of livers from ducks that have been overfed to make their livers fattier – similar to how fatty liver disease can develop in humans.
Obesity is the main risk factor for fatty liver disease. We use body mass index, or BMI, along with other tests to determine if someone is obese. A high BMI can indicate high levels of body fat. You can use the Centers for Disease Control and Prevention’s Adult BMI Calculator to learn your BMI.
This is how we use BMI scores:
- 5-25 is the normal weight range
- 25-30 is the overweight range
- 30-35 is the obese range
- 35 and higher is the morbidly obese range
Many people with fatty liver disease have a BMI of 40 or 45. Morbid obesity is a serious, potentially life-threatening condition that can increase the risk for many other health problems, such as:
Most people with fatty liver disease don’t show any symptoms. We often see patients who have been referred by their primary care doctors after a routine physical exam has shown elevated liver enzyme levels. Many of these patients already have diabetes.
Our research also has shown that genetic factors such as ethnicity may play a role in who’s at risk for fatty liver disease. We found in the Dallas Heart Study that Hispanic people are at higher risk for fatty liver disease regardless of their weight. Caucasian people have a lower overall risk than Hispanic people, and African-American people are somewhat protected from having as much fat in the liver.
It’s vital for people who are overweight or obese to lose weight. In extreme cases, when someone needs a liver transplant, we often cannot consider them for the transplant because the patient’s BMI is over 35.
But many people have a hard time losing weight or maintaining weight loss over time without additional help, such as weight loss surgery. That’s led to researchers looking for other ways to get fat out of the liver or turn off the liver’s inflammation.
Our new fatty liver disease study
We’re now involved with a clinical trial that’s examining a new medication called emricasan. This is an anti-inflammatory drug, but it’s different from drugs like aspirin or ibuprofen.
Patients in the study will have a liver biopsy, which involves taking a sample of tissue from the liver and examining it under the microscope. We’ll look to see how much inflammation the patient’s liver has and how much the liver has been scarred so far.
From there, the patient will receive the drug or a placebo, a harmless substance that doesn’t have a medical effect. This is a blind study, which means neither the patient nor the doctor will know who gets the placebo to keep the clinical trial free of bias. At the end of the trial, the patient will have another liver biopsy so we can look at any changes, and we’ll find out which patients had the medication to determine whether improvement, if any, was observed with the medication.
Who is a candidate for the fatty liver disease study?
The main criterion for participating in the clinical trial is having fatty liver disease. We can see the fat deposits in the liver during an ultrasound, and a liver biopsy will confirm whether a patient has the disease.
There are a few factors that would rule out a potential clinical trial participant. These include:
- Drinking alcohol significantly
- Having another significant liver disease, such as hepatitis B or hepatitis C
- Having uncontrolled diabetes
- Pregnancy and/or unwillingness to use effective birth control during the study
- Having cirrhosis of the liver
Though patients with cirrhosis of the liver aren’t eligible for this study, we’ll be opening a new clinical trial of this medication to patients who already have developed NASH. We think stopping the inflammation process in patients with NASH may decrease the amount of liver scarring and improve their condition.
We won’t require a liver biopsy for the forthcoming NASH cirrhosis trial, but we indirectly will be measuring the amount of portal hypertension, or high blood pressure in the patient’s portal vein, which carries blood to the digestive organs, including the liver. We’ll measure the patient’s portal hypertension before the clinical trial, provide medication or a placebo, and then measure portal hypertension again after the trial. Learn more about participating in this study.
One benefit of participating in clinical trials is the potential of having access to advanced treatment you can’t get anywhere else. But it’s also an opportunity to help advance medical science. We can’t learn more about medicine without the help of volunteers like you. Learn more about our clinical research efforts. I’m hopeful that our research will lead to doctors and patients having access to effective new treatments in the fight against these conditions.