Status:
TERMINATED
The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Patients
Lead Sponsor:
The Geneva Foundation
Conditions:
Steatohepatitis, Nonalcoholic
Hemosiderosis
Eligibility:
All Genders
10-17 years
Brief Summary
The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI
Detailed Description
The purpose of this prospective study is to determine the prevalence NAFLD and of factors that have been associated with the diagnosis of fatty liver disease in overweight and obese children and adole...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- DEERS eligible patients from the San Antonio Military Medical Center Healthy Habits clinic and pediatric endocrine, pediatric gastroenterology, adolescent, and general pediatric clinics, as well as from Wilford Hall's pediatric clinic.
- Overweight (BMI \> 85% and \< (Control group) Normal BMI for age and gender (BMI \<85%) 95% for age and gender) or obese (BMI \>/= 95% for age and gender)
- 10 - 17 years old
- Cognitively able to understand and provide written informed assent
- Written informed consent from parent or legal guardian
- Exclusion criteria:
- Current or prior history of liver disease (to include chronic hepatitis B or C, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, HIV, biliary atresia, or Caroli/choledochal disease), or other known liver disease.
- Pregnancy (self-reported or through positive beta HCG test during study)
- Current use of hepatotoxic medications associated with liver disease/failure (antifungals, methotrexate, valproic acid)
- Carrying an implantable active medical device such as a pacemaker, vagal nerve stimulator, defibrillator, or non-MRI compatible cochlear implant.
- Previous claustrophobia/anxiety with MRI scanner or developmental delays that may result in failed MRI scan (e.g.autism, anxiety disorder)
- Any alcohol use
- Predicted family PCS/loss of benefits in the next 9 months (Phase II only)
Exclusion
Key Trial Info
Start Date :
February 10 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 26 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04284371
Start Date
February 10 2016
End Date
January 26 2021
Last Update
February 24 2023
Active Locations (1)
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1
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234