Nonalcoholic Fatty Liver Clinical Trial
Official title:
Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE); An FNIH Biomarkers Consortium Study: Study 1.2
NCT number | NCT05081427 |
Other study ID # | 20-012529 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 15, 2021 |
Est. completion date | June 30, 2022 |
Verified date | November 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Foundation for the National Institutes of Health |
United States,
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 |
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