Status:
COMPLETED
Noninvasive Biomarkers of Metabolic Liver Disease 1.1
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of California, San Diego
Foundation for the National Institutes of Health
Conditions:
Nonalcoholic Steatohepatitis
Nonalcoholic Fatty Liver
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
NIMBLE is a comprehensive collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic stea...
Detailed Description
Study 1.1, is a prospective, two-center, short-term cross-sectional study to assess the reproducibility and repeatability of a set of specified ultrasound-based quantitative imaging biomarkers. The pr...
Eligibility Criteria
Inclusion
- Adult (age ≥ 18 years)
- Known or suspected NAFLD based on prior biopsy ≤ 36 months consistent with NAFLD OR
- Abnormal ALT (\>30 U/L for men, \> 19 U/L for women) without other common causes such as HCV, HBV, AND meets criteria within 36 months for ATP III criteria (2005 revision) for metabolic syndrome with any 3 of the 5:
- Waist circumference (WC) \> 102 cm (M) or \> 88 cm (F)
- Fasting glucose ≥ 100 mg/dL or Rx
- TG≥150mg/dLorRx
- SBP \> 130 mmHg
- DBP\>85mmHg or Rx
- Able and willing to participate, including maintaining steady-state: 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 participants, minimum 8, maximum 18), Intermediate likelihood of advanced fibrosis: 1.3 \< FIB-4 \< 2.67 (about one-third of enrolled participants, minimum 8, maximum 18), High likelihood of advanced fibrosis: FIB-4 ≥ 2.67: (about one-third of enrolled participants, minimum 8, maximum 18)
Exclusion
- 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 principal investigator 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 ultrasound and VCTE measurements. Women who state they might be pregnant will be required to do a urine pregnancy test to establish eligibility.
- Patients with active implants such as pacemakers or defibrillators or any other contraindication to ultrasound or VCTE scanning.
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04828551
Start Date
March 18 2021
End Date
November 20 2021
Last Update
July 11 2023
Active Locations (2)
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1
UC San Diego
San Diego, California, United States, 92103
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114