Understanding the Metabolic Pathology of Pediatric Obesity and NAFLD

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Nonalcoholic fatty liver disease (NAFLD) is now the most common liver disease worldwide and affects nearly 40% of obese youth and up to 10% of the general pediatric population. Some features of NAFLD are similar in children and adults, yet fibrosis and inflammation are more common in the portal zone and occur earlier in pediatric NAFLD patients than adults. This portends a rapid progression to end-stage liver disease in early adulthood. For the majority of children with NAFLD, mechanisms driving the origin and rapid progression of disease remain unknown. Thus, there is a critical, unmet need to study the specific underlying patterns of metabolic and molecular changes in the liver underlying the development and progression unique to children with NAFLD. This proposal will test the hypotheses that children with NAFLD have excess glucose and lipid produced by the liver, that those events are regulated by specific variations in the amount and location of RNAs and proteins in liver, and that the concentration of specific micro-RNAs in the blood can be used as a biomarker for NAFLD in pediatric patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 20
Healthy Volunteers: t
View:

• Age: All participants must be 10.0 to 20.9 years old at the time of enrollment.

• Sex: Male and Female participants are eligible.

• Race/Ethnicity: Participants of all racial/ethnic identities will be recruited.

• Body mass index (BMI): Participants must be either in the normal weight (NW control group) or obese \[Ob control, nonalcoholic fatty liver disease (NALFD) groups\] range for BMI percentile. BMI percentile will be calculated from age- and sex-specific growth charts for children.

• NAFLD status: The NAFLD group participants will be eligible if they are scheduled for liver biopsy for clinical reasons and their histopathology report confirms a diagnosis of NAFLD. NW control, and Ob control, and Liver control participants must not have diagnosed NAFLD.

Locations
United States
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Contact Information
Primary
Kevin Short, PhD
kevin-short@ouhsc.edu
405-271-8001
Time Frame
Start Date: 2022-05-25
Estimated Completion Date: 2026-06
Participants
Target number of participants: 100
Treatments
Experimental: NAFLD
Participants in the pediatric NAFLD clinic
Experimental: Ob control
Participants with obesity, without NAFLD
Experimental: NW control
Participants in the normal range for body weight, without NAFLD
Experimental: Liver control
Participants undergoing liver biopsy or liver surgery, without NAFLD
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov