Understanding liver disease in children with obesity
Understanding the Metabolic Pathology of Pediatric Obesity and NAFLD
This study is trying to understand how liver disease affects children with obesity by comparing their liver changes to those of other kids with and without the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 10 Years to 20 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05430178 on ClinicalTrials.gov |
What this trial studies
This project investigates the metabolic and molecular changes in the liver of children with nonalcoholic fatty liver disease (NAFLD) compared to age-matched controls. It employs a cross-sectional design where participants undergo metabolic tests and, for those in the NAFLD group, a liver biopsy as part of their clinical care. The study aims to identify specific RNA and protein variations that may contribute to the progression of NAFLD in pediatric patients. Control groups include obese and normal weight children without NAFLD, as well as a liver control group undergoing surgery for unrelated conditions.
Who should consider this trial
Good fit: Ideal candidates are children aged 10 to 20.9 years with a diagnosis of NAFLD or those who are obese or of normal weight without NAFLD.
Not a fit: Patients with chronic illnesses that affect metabolic variables or those with diagnosed NAFLD who are not scheduled for a liver biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to better understanding and management of NAFLD in children, potentially preventing severe liver disease.
How similar studies have performed: While studies on NAFLD exist, this specific approach focusing on pediatric populations and their unique metabolic profiles is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Chronic illness: Participants will not be able to participate if they have conditions that are likely to affect metabolic variables (either directly or due to required medications) or result in them being unable to complete the required tests. Such conditions could include, but are not limited to, untreated hypothyroidism or other endocrine disorders, rheumatoid arthritis requiring steroids or limiting mobility, cardiovascular disease, stroke, or cardiac failure, neurological disorders such as multiple sclerosis, cancer, liver diseases other than NAFLD (e.g., Wilson's disease), other organ disorders, or orthopedic conditions that limit physical activity. * Acute illness: Participants will not be able to participate if they develop acute conditions that are likely to affect metabolic outcomes (either directly or due to required medications) or result in them being unable to participate; e.g., respiratory illness, infectious disease, fever, accident resulting in bone fractures, myocardial infarction, major depression. If such conditions resolve and there are no longer risks or likelihood of adverse effect on the study outcomes, participants may be rescheduled for testing. * Medications and nutritional supplements: Medications, vitamins, or supplements that have known effects on the primary outcomes will be cause for exclusion. Examples include weight loss medications, glucocorticoids, or experimental medications used to correct a metabolic or hepatic condition. Medications used to control asthma, allergies, anxiety, depression, attention deficit disorder, menstrual cycle, hypothyroidism, gastric reflux, hypertension, and sleep will be allowed. Participants who are taking medications for treatment of acute illness or conditions such as cold, flu, injury, or infection will be rescheduled after they complete their treatment course. * Pregnancy: Evidence of pregnancy or intent to become pregnant during the study is cause for exclusion. * Smoking, alcohol abuse, or illicit drug abuse: Participants who smoke or have signs or symptoms of alcohol or substance abuse will be excluded.
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Short, PhD — University of Oklahoma
- Study coordinator: Kevin Short, PhD
- Email: kevin-short@ouhsc.edu
- Phone: 405-271-8001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.