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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Residential treatment | Patients administered for residential treatment of severe obesity will be included. Patients are treated according to standard of care in a multimodal program, focusing on increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support. Residential treatment is possible for a duration of maximum 1 year. |
| |
| Ambulatory treatment | Patients in specific pediatric obesity care pathways will be included. Patients are treated according to standard of care in a multimodal ambulatory program focusing on increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle management | Behavioral | Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of liver fibrosis | Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs. | 6 months of lifestyle intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of liver fibrosis | Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs. | 12 months of lifestyle intervention |
| Improvement of liver steatosis |
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Inclusion Criteria:
Exclusion Criteria:
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Children and adolescents with obesity (BMI higher than the 95th weight percentile)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruth De Bruyne, MD, PhD | Contact | 003293322966 | ruth.debruyne@uzgent.be |
| Name | Affiliation | Role |
|---|---|---|
| Ruth De Bruyne, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Jan Palfijn | Recruiting | Ghent | East-Flanders | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34871812 | Background | 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. | |
| 18563842 |
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The plan can be obtained by contacting the researchers with a worked-out protocol for study in which these data can be used.
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Serum samples
Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan
| 6 months of lifestyle intervention |
| Improvement of liver steatosis | Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan | 12 months of lifestyle intervention |
| Resolution of liver steatosis | 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. | 6 months of lifestyle intervention |
| Resolution of liver steatosis | 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. | 12 months of lifestyle intervention |
| Resolution of liver fibrosis | 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. | 6 months of lifestyle intervention |
| Resolution of liver fibrosis | 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. | 12 months of lifestyle intervention |
| Improvement in ALT | Proportion of patients with at least 30% decrease in serum ALT levels at follow-up, out of the patients with baseline elevated ALT | 6 months of lifestyle intervention |
| Improvement in ALT | Proportion of patients with at least 30% decrease in serum ALT levels at follow-up, out of the patients with baseline elevated ALT | 12 months of lifestyle intervention |
| University Hospital Gent | Recruiting | Ghent | East-Flanders | 9000 | Belgium |
|
| Zeepreventorium | Recruiting | De Haan | West-Flanders | 8420 | Belgium |
|
| 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. |
| 32623006 | Background | 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. |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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