Metabolic Pathology of Pediatric NAFLD

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT05430178
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 20 Years
Healthy Volunteers
Accepted

Interventions

  • Oral sugar tolerance test — OTHER
    Measurement of glucose and insulin for calculation of insulin sensitivity
  • De novo lipogenesis test — OTHER
    Oral consumption of deuterated water to measure incorporation of label into lipids
  • Gluconeogenesis test — OTHER
    Oral consumption of 13C-labeled glycerol to measure incorporation into glucose

Study Details

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.

Key Dates

Start date
May 25, 2022
Status verified
Mar 2024
Primary completion
Feb 28, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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

Primary Outcome Measure

De novo lipogenesis [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Kevin Short, PhD
[email protected]
405-271-8001

Find similar trials in Oklahoma City, OK

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OK

Related Studies