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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

Study Summary

This trial aims to better understand why NAFLD is more common & progresses faster in kids than adults, & look for clues to develop a biomarker to help diagnose & treat it.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Abundance of liver collagen

De novo lipogenesis

Gluconeogenesis

+3 more

Secondary outcome measures

Liver transcriptomics

Targets of microRNA-122

Other outcome measures

Arterial stiffness

Blood DNA analysis

Blood pressure

+4 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,825 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,403 Total Patients Enrolled

46 Trials studying Non-alcoholic Fatty Liver Disease

9,872 Patients Enrolled for Non-alcoholic Fatty Liver Disease

National Institutes of Health (NIH)NIH

2,700 Previous Clinical Trials

7,506,776 Total Patients Enrolled

8 Trials studying Non-alcoholic Fatty Liver Disease

700 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Liver control Clinical Trial Eligibility Overview. Trial Name: NCT05430178 — N/A

Non-alcoholic Fatty Liver Disease Research Study Groups: Liver control, Ob control, NW control, NAFLD

Non-alcoholic Fatty Liver Disease 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 55 and over eligible to participate in this research endeavor?

"The age restriction for this medical trial is between the ages of 10 and 20. Patients under 18 are eligible to participate in 211 other trials while those over 65 may look into 784 different studies."

Answered by AI

Does this study currently accept volunteers?

"Affirmative. According to records on clinicaltrials.gov, this research is currently soliciting applicants; it was initially posted May 25th 2022 and most recently modified February 8th 2023. This trial necessitates 100 participants from a single medical centre."

Answered by AI

What is the participant size for this experiment?

"Affirmative. Clinicaltrials.gov confirms that as of 2/8/2023, this trial is recruiting patients who meet the eligibility criteria. The study was first posted on 5/25/2022 and requires a total of 100 participants to be enrolled from one location."

Answered by AI

Is enrollment to this trial currently open?

"This clinical research is recruiting 100 minors aged 10-20 who are currently suffering from obesity. Moreover, all recruits must have a BMI that matches the age and gender specific growth chart for children, not possess any NAFLD diagnosis in their medical history, and belong to any racial or ethnic identity."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolic Pathology of Pediatric NAFLD

2022. "Metabolic Pathology of Pediatric NAFLD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05430178.

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