Clinical trial NCT04165343: Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER
Official title: Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease (NAFLD)
Nonalcoholic Steatohepatitis (NASH)
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Individuals of 18 years and older
2. NAFLD patients with diagnosis of non-alcoholic fatty liver disease will be eligible for enrollment or healthy controls without any history of fatty liver disease or risks association with fatty liver will be eligible

Brief summary: Evaluation of Multi-Organ Metabolism and Perfusion in Non-Alcoholic Fatty Liver Disease (NAFLD) by Total Body Dynamic PET Scan on EXPLORER

Detailed description: You are invited to participate in a research study that seeks to understand the effect of non-alcoholic fatty liver disease (NAFLD) on organs other than the liver. One of the most common organs affected in patients with NAFLD is the heart. We expect to have about 88 people participate in this study at University of California (UC), Davis. About three-fourths (66) of the participants will be patients who have been diagnosed with NAFLD. The other one-fourth (22) will be healthy individuals with no known liver disease. These healthy subjects will allow researchers to compare healthy organs or body functions with those of persons with NAFLD. The healthy participants are called the "Healthy Control" group. All participants will undergo the same testing.

If you agree to participate in this study, researchers will first interview you and review your medical records in order to document your medical (clinical) history. You will also have a physical examination by a doctor and a blood test. You will then undergo a series of imaging tests to determine the status of your liver, heart and other internal organs.

All participants will have a PET/CT Scan (Positron Emission Tomography), and an MRI (Magnetic Resonance Imaging). All participants will also have an Electrocardiogram and an Echocardiogram. All Electrocardiogram tests are the same, but there are two types of Echocardiogram tests. One is like a standard ultra-sound imaging of your heart. The other is a "Stress Cardio" that will require you to increase your heart rate on a treadmill before the ultra-sound test. Your study doctor will determine which test you have.

Eligibility criteria: Inclusion Criteria:

1. Individuals of 18 years and older
2. NAFLD patients with diagnosis of non-alcoholic fatty liver disease will be eligible for enrollment or healthy controls without any history of fatty liver disease or risks association with fatty liver will be eligible

Exclusion Criteria:

1. History of other liver diseases including viral hepatitis B or C (except those cured \> 3 years), autoimmune hepatitis, cholestatic diseases, significant alcohol use or known alcoholic liver disease
2. Participation in a blinded investigational study for NAFLD
3. Pregnant women
4. Prisoners
5. Claustrophobic to MRI and/or PET Scan (EXPLORER)
6. Inability to lie or to maintain posture in the scanner for one hour
7. Hgb A1c \>9%
8. Underwent dynamic FDG PET as part of another study, Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis (IRB 840422) within 12 months

Primary outcomes:
measure: Change in myocardial glucose uptake rate (K1) in patient with stage 3-4 liver fibrosis relative to stage 0-2 liver fibrosis
timeFrame: 3 years total study period. Fluorodeoxyglucose (FDG) PET scan study is for 60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
References: