Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE) Study 1.2

Recruitment & Eligibility

Inclusion Criteria

Adult (age ≥ 18 years).
Known or suspected NAFLD based on:
Prior biopsy ≤ 36 months consistent with NAFLD; OR
Clinical and laboratory data ≤ 3 months before enrollment consistent with NAFLD: abnormal ALT (>30 U/L for men, > 19 U/L for women) without other common causes such as HCV, HBV AND meets criteria or ATP III criteria (2005 revision) for metabolic syndrome with any 3 of the 5:

i. Waist circumference (WC) > 102 cm (M) or > 88 cm (F) ii. Fasting glucose ≥ 100 mg/dL or Rx iii. TG ≥ 150 mg/dL or Rx iv. Elevated blood pressure (SBP ≥ 130 mmHg or DBP ≥ 85 mmHg) v. Reduced HDL-C < 40 mg/dL (M) or < 50 gm/dL (W)
Able and willing to participate, including maintaining steady-state: diet, physical activity, alcohol use, medications.
Classifiable into one of the following enrollment categories by FIB-4 (ALT, AST, platelets, date of birth) collected at screening visit if not available already within 3 months prior:
Low likelihood of advanced fibrosis: FIB-4 ≤ 1.3 (about one-third of enrolled subjects, minimum 20%, maximum 45%);
Intermediate likelihood of advanced fibrosis: 1.3 < FIB-4 < 2.67 (about one-third of enrolled subjects, minimum 20%, maximum 45%);
High likelihood of advanced fibrosis: FIB-4 ≥ 2.67: (about one-third of enrolled subjects, minimum 20%, maximum 45%).

Exclusion Criteria

Liver disease other than NAFLD
Excess alcohol consumption (≥ 2 units/day for women and ≥ 3 units/day for men)
Current diagnosis of drug induced liver injury
Receiving drug or placebo in treatment trial now or within 30 days
Weight loss or gain of ≥ 5 kg in prior 3 months
Other factors that in the judgment of the PI might preclude study completion
Women who state they are pregnant. Women who state they are pregnant will be excluded in an abundance of caution, since pregnancy might increase intra-abdominal pressure which in turn might affect the assessment of the different-day reproducibility coefficient of MRI and VCTE measurements.
Patients with active implants such as pacemakers or defibrillators or any other contraindication to MRI or VCTE scanning.

Study & Design

Primary Outcome Measures

Name	Time	Method
Reproducibility of liver stiffness	Within 7 days	Repeatability liver stiffness in kilopascals (kPa)
Reproducibility of liver fat content	Within 7 days	Repeatability of liver proton density fat fraction (PDFF) in %
Reproducibility of visceral adipose tissue volume	Within 7 days	Repeatability of visceral adipose tissue volume measured in mL

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility