Pediatric Non-alcoholic Fatty Liver Disease
Conditions
Keywords
NAFLD, Liver fibrosis, Lifestyle management, Multidisciplinary treatment
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.
Interventions
BEHAVIORALLifestyle management
Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support.
Sponsors
University Hospital, Ghent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of liver fibrosis | 6 months of lifestyle intervention | Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of liver fibrosis | 12 months of lifestyle intervention | Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs. |
| Improvement of liver steatosis | 6 months of lifestyle intervention | Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan |
| Resolution of liver steatosis | 6 months of lifestyle intervention | Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan. Resolution of steatosis is identified as CAP \<248 dB/m at follow-up in patients with baseline CAP of 248 dB/m or higher. |
| Resolution of liver fibrosis | 6 months of lifestyle intervention | Liver fibrosis will be quantified using Fibroscan. Resolution of fibrosis is identified as liver stiffness \<7.0 kPa at follow-up in patients with baseline liver stiffness of 7.0 kPa or higher. |
| Improvement in ALT | 6 months of lifestyle intervention | Proportion of patients with at least 30% decrease in serum ALT levels at follow-up, out of the patients with baseline elevated ALT |
Countries
Belgium
Contacts
Primary ContactRuth De Bruyne, MD, PhD
Outcome results
None listed