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Metabolic Tests for Pediatric Non-alcoholic Fatty Liver Disease

N/A
Recruiting
Led By Kevin Short, PhD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NAFLD status: NAFLD group participants must be scheduled for liver biopsy for clinical reasons and have a histopathology report confirming a diagnosis of NAFLD. NW control, Ob control, and Liver control participants must not have diagnosed NAFLD
Age: Participants must be 10.0 to 20.9 years old at the time of enrollment
Must not have
Chronic illness: Participants with conditions likely to affect metabolic variables or result in inability to complete required tests will be excluded. Conditions include untreated hypothyroidism, endocrine disorders, rheumatoid arthritis requiring steroids or limiting mobility, cardiovascular disease, stroke, cardiac failure, neurological disorders, cancer, liver diseases other than NAFLD, other organ disorders, or orthopedic conditions limiting physical activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group

Summary

This trial involves taking blood and liver tissue samples from children with NAFLD to understand the disease better. It focuses on this group because they are at higher risk of rapid disease progression. Researchers aim to find specific changes in the liver and blood that can help diagnose and understand NAFLD in children.

Who is the study for?
This trial is for children and young adults aged 10 to 20.9 years with obesity or normal weight, including those diagnosed with NAFLD confirmed by liver biopsy. It's open to all genders and ethnicities. Those with chronic illnesses affecting metabolism, acute conditions, on certain medications, pregnant individuals, or substance abusers cannot participate.
What is being tested?
The study investigates metabolic changes in the liver of pediatric patients with NAFLD using tests that measure how the liver produces glucose and lipids (fats) and how it processes sugar. The goal is to identify biomarkers in blood that can indicate NAFLD.
What are the potential side effects?
Since this trial involves diagnostic tests rather than medication trials, side effects are minimal but may include discomfort from blood draws or potential reactions from substances used during testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a liver biopsy to confirm NAFLD, or I do not have NAFLD.
Select...
I am between 10 and 20 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have chronic illnesses that could affect my participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Abundance of liver collagen
De novo lipogenesis
Gluconeogenesis
+3 more
Secondary study objectives
Liver transcriptomics
Targets of microRNA-122
Other study objectives
Arterial stiffness
Blood DNA analysis
Blood pressure
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Ob controlExperimental Treatment3 Interventions
Participants with obesity, without NAFLD
Group II: NW controlExperimental Treatment3 Interventions
Participants in the normal range for body weight, without NAFLD
Group III: NAFLDExperimental Treatment3 Interventions
Participants in the pediatric NAFLD clinic
Group IV: Liver controlExperimental Treatment3 Interventions
Participants undergoing liver biopsy or liver surgery, without NAFLD

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
474 Previous Clinical Trials
93,594 Total Patients Enrolled
13 Trials studying Obesity
8,438 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,460 Previous Clinical Trials
4,336,897 Total Patients Enrolled
471 Trials studying Obesity
590,864 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,832 Previous Clinical Trials
8,170,186 Total Patients Enrolled
107 Trials studying Obesity
26,771 Patients Enrolled for Obesity
Kevin Short, PhDPrincipal InvestigatorUniversity of Oklahoma

Media Library

Liver control Clinical Trial Eligibility Overview. Trial Name: NCT05430178 — N/A
Obesity Research Study Groups: Liver control, Ob control, NW control, NAFLD
Obesity Clinical Trial 2023: Liver control Highlights & Side Effects. Trial Name: NCT05430178 — N/A
Liver control 2023 Treatment Timeline for Medical Study. Trial Name: NCT05430178 — N/A
~30 spots leftby Feb 2026
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