Clinical trial NCT05309863: Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease
Official title: Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Non-alcoholic Fatty Liver Disease
Keywords: NAFLD
Liver fibrosis
Lifestyle management
Multidisciplinary treatment
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 850
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with obesity (BMI higher than the 95th weight percentile)

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)

Primary outcomes:
measure: Improvement of liver fibrosis
timeFrame: 6 months of lifestyle intervention
Secondary outcomes:
measure: Improvement of liver fibrosis
timeFrame: 12 months of lifestyle intervention
measure: Improvement of liver steatosis
timeFrame: 6 months of lifestyle intervention
measure: Improvement of liver steatosis
timeFrame: 12 months of lifestyle intervention
measure: Resolution of liver steatosis
timeFrame: 6 months of lifestyle intervention
measure: Resolution of liver steatosis
timeFrame: 12 months of lifestyle intervention
measure: Resolution of liver fibrosis
timeFrame: 6 months of lifestyle intervention
measure: Resolution of liver fibrosis
timeFrame: 12 months of lifestyle intervention
measure: Improvement in ALT
timeFrame: 6 months of lifestyle intervention
measure: Improvement in ALT
timeFrame: 12 months of lifestyle intervention
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Jan Palfijn
state: East-Flanders
city: Gent
country: Belgium
facility: University Hospital Gent
state: East-Flanders
city: De Haan
country: Belgium
facility: Zeepreventorium
state: West-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Ruth De Bruyne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lefere S, Dupont E, De Guchtenaere A, Van Biervliet S, Vande Velde S, Verhelst X, Devisscher L, Van Vlierberghe H, Geerts A, De Bruyne R. Intensive Lifestyle Management Improves Steatosis and Fibrosis in Pediatric Nonalcoholic Fatty Liver Disease. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2317-2326.e4. doi: 10.1016/j.cgh.2021.11.039. Epub 2021 Dec 4.
citation: Nobili V, Vizzutti F, Arena U, Abraldes JG, Marra F, Pietrobattista A, Fruhwirth R, Marcellini M, Pinzani M. Accuracy and reproducibility of transient elastography for the diagnosis of fibrosis in pediatric nonalcoholic steatohepatitis. Hepatology. 2008 Aug;48(2):442-8. doi: 10.1002/hep.22376.
citation: Ciardullo S, Monti T, Perseghin G. Prevalence of Liver Steatosis and Fibrosis Detected by Transient Elastography in Adolescents in the 2017-2018 National Health and Nutrition Examination Survey. Clin Gastroenterol Hepatol. 2021 Feb;19(2):384-390.e1. doi: 10.1016/j.cgh.2020.06.048. Epub 2020 Jul 3.