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New treatment option for Non-alcoholic Fatty Liver Disease
Official title Fructose and Liver Diseases in Youth: Help Them FLY
ClinicalTrials.gov ID: NCT05528471
What this study is testing
- What it's testing
- Obesity has been increasing all over the world. This has lead to a significant increase of a liver disease in children called non-alcoholic fatty liver disease (NAFLD).
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- obese boys and girls aged 12-18 years (Tanner Stage: III-V) with clinically diagnosed NAFLD
You likely can't join if
- all patients with a history of a known primary liver disease associated with steatohepatitis (Wilson disease, various metabolic disorders, viral...
- All patients with a known primary diagnosis of Type 2 Diabetes or those on insulin;
- Patients on medications known to cause hepatic steatosis (e.g., methotrexate, corticosteroids, valproic acid, statins);
- Patients with evidence of bridging fibrosis (8); and
- Patients with a known significant history of smoking or alcohol consumption (6, 9) and
- Any patient undergoing an active weight loss program and/or who has received bariatric surgery for the treatment of obesity
See the full eligibility criteria
- obese boys and girls aged 12-18 years (Tanner Stage: III-V) with clinically diagnosed NAFLD
- all patients with a history of a known primary liver disease associated with steatohepatitis (Wilson disease, various metabolic disorders, viral hepatitis) (7);
- All patients with a known primary diagnosis of Type 2 Diabetes or those on insulin;
- Patients on medications known to cause hepatic steatosis (e.g., methotrexate, corticosteroids, valproic acid, statins);
- Patients with evidence of bridging fibrosis (8); and
- Patients with a known significant history of smoking or alcohol consumption (6, 9) and
- Any patient undergoing an active weight loss program and/or who has received bariatric surgery for the treatment of obesity
- Any participant with a cardiac pacemaker or with metal pins as this is a contraindication for MRS/MRI testing
- Any participant of child bearing potential who is known to be pregnant (as this is a contraindication to MRS/MRI) testing. All females of child bearing potential will be asked to undergo a routine pregnancy test (urine)...
- Any child with significant developmental delay or a significant co-morbidity that precluded the ability to participate in study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.