Looming Epidemics: Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) - High Point Clinical Trials Center

Looming Epidemics: Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH)

Looming Epidemics: Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH)

Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) are looming epidemics and currently the intense focus of the academic, pharmaceutical and medical industry.

Dr. Margarita Nuñez, Medical Director/Principal Investigator at High Point Clinical Trials Center, elaborates on this epidemic and how reaching out to the community is a crucial component of tackling this growing issue.

Dr. Margarita Nunez, Medical Director

As Dr. Nuñez shares, there have always been concerns with the complications that come with diabetes, but one of the common issues that went undiagnosed for a while—even in clinical settings—was an elevation in patients’ liver enzymes.

“Over time, experts in the medical field began to recognize the damage to the liver that comes from and is caused by metabolic abnormalities. It used to be assumed that individuals with abnormal liver enzymes were “closet drinkers.” However, a number of patients would never drink at all, which led experts to further investigate liver damage and its connection to diabetes and metabolic disorders,” she explains.

Dr. Nunez continues “Initially, when presented with a patient experiencing damage to the liver, doctors would typically use an ultrasound to check for illnesses like Hepatitis, but in several cases, they often assumed it was a viral issue. Now, doctors and researchers have since been able to identify this condition as Non-Alcoholic Fatty Liver Disease (NAFLD) that can progress to Non-Alcoholic Steatohepatitis (NASH) and even Cirrhosis. NAFLD is described as fatty infiltration of the liver without evidence of inflammation, whereas NASH refers to fatty infiltration of the liver with the presence of inflammation.”

“It is imperative to understand that NAFLD and NASH are conditions that cannot be taken lightly. The damage to the liver is a real medical problem that in many cases can be life threatening. What is even more alarming is that victims of this disease typically do not even know they have it—in fact, it can go undetected for years. Therefore, bringing awareness to the condition within the community is of utmost importance.”

So, what is the best way to treat people who have this underlying liver damage?

Dr. Nuñez points out, “Like many metabolically related diseases, the current recommendation is lifestyle modification. However, while poor dietary choices and lack of exercise heavily contribute, there is evidence to suggest underlying genetic factors could affect metabolism of fats and lipids, leading to the accumulation of fatty deposits in the liver.”

Therapies are under development for both diseases, but currently there are no approved drugs to treat them. So, for now, the major effort must be directed towards patient education, and most importantly the positive impact that can be made through early diagnosis.

Dr. Nuñez emphasizes, “It’s really important to identify the problem even if there is no cure. Realistically, there is something you can do to make a difference. You can change your lifestyle and try to improve your parameters. Patients with this condition could also be entering into research to potentially help people in the future or they could join a clinical trial for possible treatment.”

NAFLD affects anywhere from 6-35% of people in the United States and refers to the presence of fat after other causes for secondary fat have been ruled out, including heavy alcohol use. Risk factors for this condition include obesity, Type 2 Diabetes, Dyslipidemia and Metabolic Syndrome. NASH, on the other hand, affects approximately 3-5% of people in the United States, diagnosed by hepatic inflammation via biopsy or fibroscan, or a confluence of other non-invasive metabolic parameters.

High Point Clinical Trials Center (HPCTC) works in the North Carolina and more specifically the Piedmont Triad region to help the community understand NAFLD and NASH or its emerging stages. Dr. Nunez explains, “We have been developing a screening initiative to invite people who are concerned about NASH or potential liver injury to come in, and we will do some basic tests and discuss the results.”

In addition to the screening initiative, HPCTC’s medical staff volunteer at the Community Clinic of High Point to help identify patients who could benefit from intervention and bring awareness to the problems they are encountering. The center has also recently launched a 33’ Recreational Vehicle (RV), “health center on wheels,” designed to support a wide range of screenings and bringing mobility to the outreach effort by expanding the bandwidth to the entire Triad region and beyond.

These initiatives are a critical first step in the journey towards raising patient awareness and helping advance promising new therapies to the market.