Back to search results

Understanding Metabolic Changes in Pediatric NAFLD

This study aims to understand the metabolic changes in children and young adults (ages 10-20) with Nonalcoholic Fatty Liver Disease (NAFLD), a common liver condition. Researchers will use special tests like an oral sugar tolerance test (to measure how your body handles sugar), a de novo lipogenesis test (to see how your body makes fat), and a gluconeogenesis test (to see how your body makes sugar). These tests involve consuming special water or glycerol. The study will compare participants with NAFLD to those who are obese or have a normal weight. The goal is to learn more about why NAFLD develops and progresses quickly in young people. This study is currently unclear on its recruitment status and plans to enroll 100 participants.

Study design
This is an interventional study with a cross-sectional design, meaning participants are tested once. It plans to enroll 100 participants.
What's involved
You would complete metabolic and descriptive tests, including blood analyses. If you have NAFLD, a portion of a liver biopsy done as part of your standard care would be used for research.
Compensation
Not stated in the trial record.
Follow-up
This study has a single testing period without a formal follow-up period. Measurements are taken on Day 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05430178

Metabolic Pathology of Pediatric NAFLD

UNKNOWN
NAAges 10–20InterventionalBasic science
University of Oklahoma
~100 participants
Updated 2024-03-06 on ClinicalTrials.gov
What's tested:Oral sugar tolerance testDe novo lipogenesis testGluconeogenesis test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
De novo lipogenesis
Measured over Day 1
+5 more outcomes measured

Conditions

Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Obesity

Explore related trials

Nonalcoholic Fatty Liver DiseaseObesity

Where it's being run

1 sites across 1 states
Oklahoma1

Study leadership

  • Kevin Short, PhD · PRINCIPAL_INVESTIGATOR · University of Oklahoma

Who to contact

Kevin Short, PhD
[email protected]
405-271-8001 · ext. 43094
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • De novo lipogenesisDay 1

    Measurement of the rate of newly synthesized triglycerides in plasma using deuterated water

  • GluconeogenesisDay 1

    Measurement of the rate newly synthesized glucose in circulation using labeled glycerol and deuterated water

  • Serum microRNADay 1

    Abundance of microRNAs in serum using a broad profiling platform and real-time quantitative polymerase chain reaction tests for confirming individual miRNAs

  • Abundance of liver collagenDay 1

    Abundance of collagen in liver biopsy sections, using Second Harmonic Generation microscopy

  • Liver mitochondrial fluxDay 1

    Reported as the fluorescent lifetime redox ratio (FLIRR), which is calculated from measurements of free and bound NADH and FAD in liver biopsy sections, using fluorescence lifetime imaging microscopy

  • Insulin sensitivityDay 1

    Calculated value of insulin sensitivity, using the oral minimal model and serial concentrations of glucose and insulin during an oral sugar tolerance test