Obesity, Childhood Clinical Trial
Official title:
The Prevalence of Liver Steatosis, Steatohepatitis, Fibrosis, and Hemosiderosis in Overweight and Obese US Military Dependent Pediatric Patients Using MR Elastography and Quantitative MRI
Verified date | February 2023 |
Source | The Geneva Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI
Status | Terminated |
Enrollment | 150 |
Est. completion date | January 26, 2021 |
Est. primary completion date | January 26, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. 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) 3. 10 - 17 years old 4. Cognitively able to understand and provide written informed assent 5. Written informed consent from parent or legal guardian Exclusion criteria: 1. 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. 2. Pregnancy (self-reported or through positive beta HCG test during study) 3. Current use of hepatotoxic medications associated with liver disease/failure (antifungals, methotrexate, valproic acid) 4. Carrying an implantable active medical device such as a pacemaker, vagal nerve stimulator, defibrillator, or non-MRI compatible cochlear implant. 5. Previous claustrophobia/anxiety with MRI scanner or developmental delays that may result in failed MRI scan (e.g.autism, anxiety disorder) 6. Any alcohol use 7. Predicted family PCS/loss of benefits in the next 9 months (Phase II only) |
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The Geneva Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LiverMultiScan (LMS) | LMS Imagery will be used to for observance of the prevalence of liver fibrosis, steatosis, steatohepatitis and hemosiderosis on LMS in overweight and obese US Military dependents between ages 10 and 17 | 2 years | |
Primary | MRE | MRE imagery will be used as a comparison to the LMS imagery to help determine Liver stiffness as measured by MRE overweight and obese US Military dependents between ages 10 and 17after a 9 month intervention | 24 |
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