Metabolic Pathology of Pediatric NAFLD

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This project uses a cross-sectional design with a single testing period without a formal intervention (e.g., diet, drug, exercise) or natural follow-up period. Participants with nonalcoholic fatty liver disease (NAFLD), and age-matched control groups classified as either obese (Ob control) or normal weight (NW control) will complete all metabolic and descriptive tests, including blood analyses. The NAFLD group will also have a liver biopsy as part of their standard clinical care; a portion of the biopsy will be used for the research testing. The Ob and NW control groups will not undergo liver biopsy. To provide a set of reference liver samples to compare with the NAFLD group, we will enroll a "liver control" group, consisting of age-matched patients who are scheduled to have a cholecystectomy with liver biopsy or are undergoing liver resection for tumor removal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05430178
Study type	Interventional
Source	University of Oklahoma
Contact	Kevin Short, PhD
Phone	405-271-8001
Email	kevin-short@ouhsc.edu
Status	Recruiting
Phase	N/A
Start date	May 25, 2022
Completion date	June 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04243317` - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults	N/A
Recruiting	`NCT04101669` - EndoBarrier System Pivotal Trial(Rev E v2)	N/A
Terminated	`NCT03772886` - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball	N/A
Completed	`NCT03640442` - Modified Ramped Position for Intubation of Obese Females.	N/A
Completed	`NCT04506996` - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2	N/A
Recruiting	`NCT06019832` - Analysis of Stem and Non-Stem Tibial Component	N/A
Active, not recruiting	`NCT05891834` - Study of INV-202 in Patients With Obesity and Metabolic Syndrome	Phase 2
Active, not recruiting	`NCT05275959` - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)	N/A
Recruiting	`NCT04575194` - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy	Phase 4
Completed	`NCT04513769` - Nutritious Eating With Soul at Rare Variety Cafe	N/A
Withdrawn	`NCT03042897` - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer	N/A
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Recruiting	`NCT05917873` - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation	N/A
Active, not recruiting	`NCT04353258` - Research Intervention to Support Healthy Eating and Exercise	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Recruiting	`NCT03227575` - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control	N/A
Completed	`NCT01870947` - Assisted Exercise in Obese Endometrial Cancer Patients	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting	`NCT05972564` - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function	Phase 1/Phase 2
Recruiting	`NCT05371496` - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.