An Imaging-based Quantitative Biomarker Assay for NAFLD in Children
This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI).
Conditions:
🦠 NAFLD 🦠 NASH
🗓️ Study Start (Actual) 1 April 2024
🗓️ Primary Completion (Estimated) 1 April 2026
✅ Study Completion (Estimated) 1 April 2027
👥 Enrollment (Estimated) 24
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Madison, Wisconsin, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Age: 10 - 14years old
    • 2. BMI: Case subjects: BMI\>95th percentile for age and sex Healthy BMI volunteers: 5th ≤ BMI \< 85th percentile for age and sex

    Exclusion Criteria:

    • 1. Children with contraindications to MRI.
    • 2. Children who did not fast (verbally confirmed by children or guardian)
    • 3. Pregnant
Ages Eligible for Study: 10 Years to 14 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 April 2024
  • First Submitted that Met QC Criteria 3 April 2024
  • First Posted 9 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 April 2024
  • Last Update Posted 9 April 2024
  • Last Verified April 2024