The University of Florida won a $2.3 million grant in its quest to investigate liver scarring and inflammation triggered by fatty liver. The National institutes of Health (NIH)-based grant enables UF to enroll up to 1,050 patients during the next two and-a-half years. By scanning 525 patients with Type 2 diabetes and another 525 participants without Type 2 diabetes, UF considers this “the largest fatty liver study of its kind in the U.S.”
A Looming Crisis
Fatty liver caused scarring is a potential killer and enormous numbers of people are at risk and are completely oblivious to the diseases’ existence, reports Bill Levesque writing for UF Health News. Even many physicians remain uncertain of its prevalence, reports Levesque. With scarring incurred by inflammation due to the fatty liver, types include non-alcoholic fatty liver disease (NAFLD) and alcoholic liver disease. TrialSite has chronicled the threat of this class of disease.
UF Health News’ Levesque reports in preliminary research, although limited in scope revealed that 70% of 561 people with Type 2 diabetes who were screened had a fatty liver on imaging; 21% had some degree of liver fibrosis and 9% had severe fibrosis or cirrhosis reported co-author Kenneth Cusi, MD, and other UF Health investigators who had their findings published in Diabetes Care, the official journal of the American Diabetes Association.
Now the UF investigators have been awarded $2.3 million in NIH funding to screen over 1,000 patients at the health center outpatient clinics over the next two-and-a-half years to determine the pervasiveness of the conduct. UF Health News reports it’s the first study of its kind in the United States.
The study team will seek to scan the livers of 525 people with Type 2 diabetes to detect the presence of scarring while another 525 will be part of a control group, that is those people without diabetes to be scanned.
While NAFLD is a known side effect of Type 2 diabetes, especially for those that are obese; real damage can result including liver inflammation that can lead to cirrhosis, liver failure, even death.
In the current study, patients who are screened for liver inflammation and fibrosis at outpatient primary care clinics, including general internal medicine, family medicine and endocrinology, will be assessed, if they agree to participate and meet eligibility requirements.
Half the patients found to have a liver scarring will be offered a drug called pioglitazone, which has shown promise in curbing the progression of the disease, along with a diet and exercise regimen. Weight loss brought on by lifestyle changes is one of the primary ways to fight the accumulation of liver fat.
Principal Investigator Point of View
Kenneth Cusi, MD, and chief of the UF College of Medicine’s division of endocrinology, diabetes and metabolism reports, “This study will be designed to offer the first unbiased estimate of how many people with Type 2 diabetes are just walking out there progressively diving into cirrhosis without even knowing it.” Dr. Cusi continued, “We know it’s a big problem. But its being missed.”
The study results may help inform or even guide national policy on guidelines for how people with diabetes are screened as this condition represents a leading cause of liver transplantation in the U.S.
Dr. Cusi suggests, “The ultimate goal is to diagnose scarring—the medical term is fibrosis—at an early stage to prevent people from developing cirrhosis.” Prevention is absolutely key—getting to these problems before its too late reports UF News.
Kenneth Cusi, MD, and chief of the UF College of Medicine’s division of endocrinology, diabetes and metabolism
Other participating researchers can be viewed at the source.