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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
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
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 moreSecondary study objectives
Liver transcriptomics
Targets of microRNA-122
Other study objectives
Arterial stiffness
Blood DNA analysis
Blood pressure
+4 moreTrial 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
467 Previous Clinical Trials
91,213 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,428 Previous Clinical Trials
4,322,631 Total Patients Enrolled
50 Trials studying Non-alcoholic Fatty Liver Disease
9,598 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institutes of Health (NIH)NIH
2,789 Previous Clinical Trials
8,138,044 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
760 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have chronic illnesses that could affect my participation.I am not taking any medications or supplements that affect weight, metabolism, or liver conditions.I am scheduled for a liver biopsy to confirm NAFLD, or I do not have NAFLD.My BMI is in the normal or obese range according to my age and sex.I am between 10 and 20 years old.I am either male or female.I do not have any current severe illnesses that could affect the study.
Research Study Groups:
This trial has the following groups:- Group 1: Liver control
- Group 2: Ob control
- Group 3: NW control
- Group 4: NAFLD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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