Metabolic Tests for Pediatric Non-alcoholic Fatty Liver Disease
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Oklahoma
Must not be taking: Weight loss drugs, glucocorticoids
Disqualifiers: Chronic illness, acute illness, pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
You can continue taking medications for asthma, allergies, anxiety, depression, attention deficit disorder, menstrual cycle, hypothyroidism, gastric reflux, hypertension, and sleep. However, if you're on medications that affect weight loss or are experimental for metabolic or liver conditions, you may not be eligible to participate.
How does this treatment for pediatric non-alcoholic fatty liver disease differ from others?
This treatment uses the Single Point Insulin Sensitivity Estimator (SPISE), a novel and inexpensive method to estimate insulin resistance in children with non-alcoholic fatty liver disease, which is more effective than traditional methods.
12345Eligibility Criteria
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.Inclusion Criteria
Race/Ethnicity: Participants of all racial/ethnic identities will be recruited
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.
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Exclusion 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.
Smoking, alcohol abuse, or illicit drug abuse: Participants who smoke or show signs of alcohol or substance abuse will be excluded
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Testing
Participants undergo metabolic and descriptive tests, including blood analyses and liver biopsy for the NAFLD group
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after testing
4 weeks
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Oklahoma Health Sciences CenterOklahoma City, OK
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Who Is Running the Clinical Trial?
University of OklahomaLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
National Institutes of Health (NIH)Collaborator
References
Impaired glucose tolerance and type 2 diabetes mellitus: a new field for pediatrics in Europe. [2022]Several studies have shown that obese children and adolescence seem to have an increased risk to develop a disturbed glucose metabolism as already known for obese adults. This might result in the same disastrous outcomes of cardiovascular diseases as it has been shown for adult obese patients. The most sensitive measurement for detecting changes in glucose metabolism in obese children seems to be an oral glucose tolerance test (OGGT) which is not practical for all daily outpatient clinics.
Single Point Insulin Sensitivity Estimator in Pediatric Non-Alcoholic Fatty Liver Disease. [2022]Attenuated insulin-sensitivity (IS) is a central feature of pediatric non-alcoholic fatty liver disease (NAFLD). We recently developed a new index, single point insulin sensitivity estimator (SPISE), based on triglycerides, high-density-lipoprotein and body-mass-index (BMI), and validated by euglycemic-hyperinsulinemic clamp-test (EHCT) in adolescents. This study aims to assess the performance of SPISE as an estimation of hepatic insulin (in-)sensitivity. Our results introduce SPISE as a novel and inexpensive index of hepatic insulin resistance, superior to established indices in children and adolescents with obesity.
Changes in liver enzymes are associated with changes in insulin resistance, inflammatory biomarkers and leptin in prepubertal children with obesity. [2023]Non-alcoholic fatty liver disease is associated with obesity. A subclinical inflammation state, endothelial dysfunction, and parameters related to metabolic syndrome (MetS), have been documented in children with obesity. We aimed to determine the changes that occur in liver enzymes levels in response to the standard treatment of childhood obesity, also assessing any associations with liver enzyme levels, leptin, and markers of insulin resistance (IR), inflammation, and parameters related to MetS in prepubertal children.
Obesity, insulin resistance, and other clinicopathological correlates of pediatric nonalcoholic fatty liver disease. [2022]To describe the clinical characteristics of nonalcoholic fatty liver disease (NAFLD) in children, including insulin resistance, and to test for correlation with liver pathology.
Repetitiveness of the oral glucose tolerance test in children and adolescents. [2021]Data regarding the most suitable diagnostic method for the diagnosis of glucose impairment in asymptomatic children and adolescents are inconclusive. Furthermore, limited data are available on the reproducibility of the oral glucose tolerance test (OGTT) in children and adolescents who are obese (OB).