Penn State researchers developed a first-of-its-kind clinical trial to investigate the impact of exercise on a severe form of nonalcoholic fatty liver disease. This study precludes drugs as they are often ineffective and trigger side effects in NASH patients. Called the NASH Fitness Intervention in Thrombosis or NASHFit, the study design itself was showcased recently in the journal Contemporary Clinical Trials Communications. Will investigative teams increasingly look to more holistic, preventive modes of study with less dependence on drugs?
What is NASH?
Nonalcoholic fatty disease represents the leading cause of chronic liver disease in the United States, and as TrialSite News has reported on in the past, represents a not-well-known but emerging health crisis on the scale of type 2 diabetes.
This disease originates from the accumulation of fat build up, unrelated to alcohol use, in patient’s liver cells. The disease often emerges as a comorbidity associated with individuals struggling with significant weight challenges and obesity, diabetes or high cholesterol.
In its severe progression, the disease becomes nonalcoholic steatohepatitis or NASH. If a patient with NASH doesn’t exercise and take other health measures, the disease can lead to liver cancer or end-stage liver disease, necessitating liver transplantation. Already, NASH is the number one reason for liver transplantation in women and it is expected to be the most common reason for both men and women in just five years
NASH & Blood Clots
As it turns out those, patients with end-stage liver disease from NASH face a greater risk for blood clots, including those in the blood vessel that bring blood to the liver from the intestines. This can create complications for those that need a liver transplant; this condition can also shorten the life of a person that receives a liver transplant.
The Study Hypothesis
The investigators suggest exercise can lower clotting risk in both healthy people and people with vascular disease. Hence the investigational team will assess if supervised aerobic exercise can reduce levels of a specific protein that contributes to blood clots in patients with NASH.
The Penn State researchers believe that the specific blood clot creating protein will be significantly reduced in participants who receive the exercise training. The team will also collect and measure levels of liver fat, liver scar tissue, physical fitness, body fat composition, weight and quality of life. This study is novel in that it doesn’t use drug treatments. As is the case with NASH patients, most drugs are ineffective and cause side effects.
The research team wrote recently, “The timing of the NASHFit study is crucial given the worsening epidemic of metabolic disease.”
The NASHFit Study
The investigators commenced the study of patients who are randomly assigned to one of two groups. Group one receives 16 weeks of exercise training, including supervised aerobic training sessions with an American College of Sports Medicine-certified exercise physiologist and dietary counseling from a registered dietician. The control group will be asked to maintain their current clinical care at the direction of their healthcare provider. Members of this second group will receive basic information from the American Liver Foundation to reinforce the guidance of the healthcare provider. The participants will receive weekly phone calls from the study team.
The team will recruit 42 participants for the NASHFit study, using the Clinical Research Center (part of the Penn State Clinical and Translational Science Institute) as a location for some study visits. The Clinical Research Center offers compelling infrastructure, including specialized nursing support and administrative services for human subjects research. These dedicated research units are located in the Penn State Health Milton S. Hershey Medical Center in Hershey and Noll Laboratory at Penn State University Park.
Dr. Jonathan Stine, Penn State Health Liver Center research director and principal investigator, commented, “We are very fortunate at Penn State Health and Penn State College of Medicine to have access to the immense research resources of both Clinical Research Center and Penn State Clinical and Translational Science Institute.” The study team includes Stine, Dr. Ian Schreibman, Seyedehsan Navabi, Mitchell Kang, Jessica Dahmus, Gloriany Rivas, Breianna Hummer, Megan Byer, Heather Tressler, all of Division of Gastroenterology and Hepatology, Department of Medicine; Christopher Soriano and Dr. Christopher Sciamanna, Department of Medicine; Scot R. Kimball, Department of Physiology; Andrew D. Patterson, Department of Biochemistry and Molecular Biology and Kathryn Schmitz, Departments of Kinesiology and Physical Medicine and Rehabilitation.
Penn State Clinical Research Center (CRC)
The Penn State CRC provides research infrastructure for investigators who conduct research with human participants. The CRC is part of Penn State Clinical and Translational Science Institute’s clinical services function. A Clinical Research Center Advisory Committee provides oversight and all protocols are approved by this committee before a study can commence. Institutional Review Board approval is also required.
The study is funded via funds from the National Institutes of Health (L30 DK118601), Pennsylvania Department of Health using Tobacco CURE Fund, and National Center for Advancing Translational Sciences through Penn State Clinical and Translational Science Institute (UL1TRoo2014).
Call to Action: Interested in learning more about the study? Contact Gloriany Rivas, Clinical Research Coordinator BA717-531-0003 ext 320223 or at email@example.com. The head nurse of the CRC in Hershey is Shirlynn Mottilla; Charity Sauder is the CTSI Administrative Director.