Actively Recruiting
Metabolic Pathology of Pediatric NAFLD
Led by University of Oklahoma · Updated on 2024-03-06
100
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metabolic Pathology of Pediatric NAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 10.0 and 20.9 years at enrollment
- Male and female participants are eligible
- Participants of all racial and ethnic backgrounds are included
- Participants must have BMI in either normal weight or obese range based on age- and sex-specific percentiles
- NAFLD group requires clinical liver biopsy confirmation of diagnosis
- Control groups (normal weight, obese, and liver control) must not have diagnosed NAFLD
You will not qualify if you...
- Chronic illnesses affecting metabolism or ability to complete tests, such as untreated hypothyroidism, endocrine disorders, rheumatoid arthritis requiring steroids, cardiovascular disease, neurological disorders, cancer, liver diseases other than NAFLD, other organ disorders, or orthopedic conditions limiting activity
- Acute illnesses that affect metabolism or participation such as respiratory infections, infectious diseases, fever, fractures, myocardial infarction, or major depression
- Use of medications or supplements known to affect study outcomes, including weight loss drugs, glucocorticoids, or experimental metabolic or liver drugs; medications for asthma, allergies, anxiety, depression, ADHD, menstrual cycle, hypothyroidism, gastric reflux, hypertension, and sleep are allowed
- Pregnancy or intention to become pregnant during the study
- Smoking or evidence of alcohol or substance abuse
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
K
Kevin Short, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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