NCT05309863 Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease
| NCT ID | NCT05309863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Pediatric Non-alcoholic Fatty Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 850 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 850 participants in total. It began in 2022-05-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent chronic liver disease worldwide, paralleling the obesity pandemic. Secondary to increasing rates of obesity in children and adolescents, the prevalence of NAFLD has more than doubled in the last decades and is now the most common pediatric liver disease. At present, lifestyle modification by dietary intervention and increasing physical activity is the mainstay of treatment for pediatric NAFLD. Several studies have shown that lifestyle intervention and weight loss improve non-invasive markers of NAFLD. To the investigator's knowledge, data on fibrosis regression following lifestyle treatment in children and adolescents were lacking. The investigators therefore performed a prospective cohort study to investigate the impact of residential lifestyle treatment on liver steatosis and fibrosis in obese children and adolescents. As a follow-up, the investigators now aim to compare these findings with a cohort of well-characterized patients undergoing multidisciplinary, yet ambulatory, weight loss treatment. As such, the investigators will compare the outcomes in two prospective patient cohorts in this non-randomized observational study.
Eligibility Criteria
Inclusion Criteria: * Enrolled in the lifestyle management program for obesity in one of the participating centres Exclusion Criteria: * Syndromic obesity * Evidence of liver disease of other causes (viral, auto-immune, genetic) * Average daily alcohol consumption of \>20g/day * Unvalid screening Fibroscan * Treatment with drugs which can induce liver steatosis or fibrosis (e.g. systemic corticosteroids, methotrexate)
Contact & Investigator
Ruth De Bruyne, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT05309863 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Pediatric Non-alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05309863 currently recruiting?
Yes, NCT05309863 is actively recruiting participants. Contact the research team at ruth.debruyne@uzgent.be for enrollment information.
Where is the NCT05309863 trial being conducted?
This trial is being conducted at Ghent, Belgium, Ghent, Belgium, De Haan, Belgium.
Who is sponsoring the NCT05309863 clinical trial?
NCT05309863 is sponsored by University Hospital, Ghent. The principal investigator is Ruth De Bruyne, MD, PhD at University Hospital, Ghent. The trial plans to enroll 850 participants.