Alina M. Allen, M.D., M.S.

The purpose of this study is to collect raw ultrasound data, using an FDA-approved portable ultrasound transducer, from patients with confirmed or suspected liver disease, or a liver graft (transplant). Oncoustics is developing AI-based software which detects and characterizes liver fibrosis, steatosis, inflammation, hepatic decompensation associated with cirrhosis, and a variety of liver lesions including hepatocellular carcinoma.  

The aim of the study is to understand which baseline  factors are associated with the progression of Nonalcoholic Fatty Liver Disease (NAFLD), and to evaluate the progression of NAFLD using magnetic resonance elastography (MRE) and a type of ultrasound called vibration-controlled transient elastography (VCTE). Patients will undergo yearly review of medical history, vitals, physical examination, blood work, and VCTE.

Blood work will be testing for traits of metabolic syndrome including markers for diabetes (hemoglobin A1C, fasting glucose) and hyperlipidemia (lipid panel). Every two years an MRE awill be performed to assess liver stiffness and fat fraction, up to three exams total for the duration of the study. Results from the subjects medical history, physical exam, and radiographic imaging will be used together with genetic data to form a better understanding of factors that can lead to the progression of NAFLD and NAFLD related cirrhosis.

About this study

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world and a major public health issue in the US. It is estimated to affect 1 in 4 adults and it is most commonly found in people who are overweight or obese. Because it is a silent disease (without symptoms until end stage) and the lab tests can be normal, it can be missed in early stages. The fat in the liver can lead to inflammation and eventually scar deposition, which can progress to cirrhosis, liver cancer and need for liver transplantation.

This study aims to assess how common this disease is in Olmsted County, what markers can identify the disease early to prevent progression to cirrhosis and what other medical problems occur in people with NAFLD in addition to the liver complications. We plan to enroll a large number of adults, assess their liver with state-of-the-art tests available at Mayo Clinic and follow them over several years to monitor for disease progression and other health complications. The ultimate goal of the study is to identify new markers that predict presence of fatty liver and poor health outcomes, in order to improve population health in the community.

Participation eligibility

Participants will be identified from the Olmsted County population age 18 or older.

Inclusion criteria:

1.         Adults age 18 years or older

2.         Olmsted County residents at the time of study entry

Exclusion criteria:

1.         Pediatric population (age<18)

2.         Unwilling to participate or unable to consent

3.         Known liver disease other than NAFLD at the time of survey

4.         Pregnant women

5.         Alcohol use in excess (14 drinks or more per week for women and 21 drinks or more per week for men)

TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFLD or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients with NAFLD or NASH within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

The primary objective of this study is to evaluate the safety and tolerability of GS-0976 in adults with nonalcoholic steatohepatitis (NASH).

The purpose of this study is to evaluate the effect of Aramchol as compared to placebo on NASH resolution, fibrosis improvement and clinical outcomes related to progression of liver disease (fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes).

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.

The purpose of this study is to assess the correlation of Hepatoscope measurements with MRI-based non-invasive measurements of liver steatosis and stiffness.

The primary objective for PART 1 of this study is to demonstrate that treatment with semaglutide s.c. 2.4 mg improves liver histology compared to placebo in subjects with NASH and fibrosis stage 2 or 3.

The primary objective for PART 2 of this study is to demonstrate that treatment with semaglutide s.c. 2.4 mg lowers the risk of liver-related clinical events compared to placebo in subjects with NASH and fibrosis stage 2 or 3.

A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information but yet is not available non-invasively. Recent murine studies from this group of investigators has identified that MRE technology can be adapted to non-invasively detect these conditions. Implementing this into the practice will transform it by obviating the need for invasive liver biopsies in patients suspected of having such forms of suspected liver disease. This will differentiate Mayo from other institutions where such technology is not available.

An additional aim of this study is to examine the impact of obstructive sleep apnea (OSA) on the pathogenesis of nonalcoholic fatty liver disease (NAFLD), both common comorbidities of obesity. Recent evidence indicates a potential link between OSA and severity of NASH and fibrosis, but the mechanisms of OSA- associated hypoxia on liver disease progression in NAFLD is unclear. This study offers the unique opportunity to analyze this association, as the study population will undergo routine evaluation for OSA, as part as the preoperative work-up prior to bariatric surgery.