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

Nonalcoholic Fatty Liver Clinical Trial

Official title:

Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE); An FNIH Biomarkers Consortium Study: Study 1.2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05081427
• Other study ID #: 20-012529
• Status: Completed
• Start date: November 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a prospective, observational, single-center, short-term cross-sectional study to assess the repeatability and reproducibility of a set of specified MRI quantitative biomarkers.

Description:

NIMBLE is a comprehensive, five-year collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic steatohepatitis (NASH), and to predict and assess response to therapeutic intervention (https://fnih.org/what-we-do/biomarkers-consortium/programs/nimble). The purpose of this study is to assess the repeatability and reproducibility of a set of specified MRI quantitative biomarkers. The imaging biomarkers will cover an array of methods that could be applicable to non-alcoholic fatty liver disease (NAFLD), including liver fat, liver stiffness, corrected T1 relaxation time and body composition assessments. The data collected will be used to inform a decision of which of these biomarkers has sufficient precision to be advanced to NIMBLE Stage 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

1. Liver disease other than NAFLD

2. Excess alcohol consumption (= 2 units/day for women and = 3 units/day for men)

3. Current diagnosis of drug induced liver injury

4. Receiving drug or placebo in treatment trial now or within 30 days

5. Weight loss or gain of = 5 kg in prior 3 months

6. Other factors that in the judgment of the PI might preclude study completion

7. 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.

8. Patients with active implants such as pacemakers or defibrillators or any other contraindication to MRI or VCTE scanning.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Foundation for the National Institutes of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility of liver stiffness	Repeatability liver stiffness in kilopascals (kPa)	Within 7 days
Primary	Reproducibility of liver fat content	Repeatability of liver proton density fat fraction (PDFF) in %	Within 7 days
Primary	Reproducibility of visceral adipose tissue volume	Repeatability of visceral adipose tissue volume measured in mL	Within 7 days

External Links

•   Mayo Clinic Clinical Trials