The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Patients

NCT04284371 | Terminated

• 1 other identifier: C.2016.01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Steatohepatitis, Nonalcoholic; Hemosiderosis; Overweight Adolescents; Obesity, Childhood; Liver Steatosis

Keywords

Liver Steatosis; Overweight Adolescents

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Military dependent population male and females age 10-17 years of age

You may qualify if:

• 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)
• years old
• Cognitively able to understand and provide written informed assent
• Written informed consent from parent or legal guardian

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Geneva Foundation: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Hemosiderosis; Pediatric Obesity; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Iron Overload; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Carlosn, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: February 25, 2020
• Study Start: February 10, 2016
• Primary Completion: January 26, 2021
• Study Completion: January 26, 2021
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1)