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Pediatric Non-alcoholic Fatty Liver DiseaseNCT05309863

Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease

An observational study of Pediatric Non-alcoholic Fatty Liver Disease, run by University Hospital, Ghent at 3 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 18 years
What is being tested?
Lifestyle management
How many people
850 participants
Where
3 sitesBelgium
Study dates
1 May 2022to 31 Dec 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Children and adolescents with obesity (BMI higher than the 95th weight percentile)

Who may be able to join

  • Enrolled in the lifestyle management program for obesity in one of the participating centres

Who cannot join

  • 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)

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ruth De Bruyne, MD, PhD contact

003293322966

ruth.debruyne@uzgent.be

Belgium3 sites, 3 recruiting

  • Zeepreventorium

    De Haan, West-Flanders, 8420

    Ellen Dupont, MD

    Ellen Dupont, MD

    Recruiting

  • AZ Jan Palfijn

    Ghent, East-Flanders, 9000

    Nele Baeck, MD

    Nele Baeck, MD

    Recruiting

  • University Hospital Gent

    Ghent, East-Flanders, 9000

    Ruth De Bruyne, MD, PhD, 003293323966, ruth.debruyne@uzgent.be

    Sander Lefere, MD, PhD, sander.lefere@ugent.be

    Recruiting

Other trials in Belgium

About this study

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.

Being tested
Lifestyle management
Keywords
NAFLD, Liver fibrosis, Lifestyle management, Multidisciplinary treatment
Medical subject headings
Non-alcoholic Fatty Liver Disease, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle managementBehavioural

    Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support.

Study groups in NCT05309863
Study groupRoleWhat they receive
Residential treatmentPatients 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.
Receives: Behavioral: Lifestyle management
Ambulatory treatmentPatients 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.
Receives: Behavioral: Lifestyle management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of liver fibrosis

    Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs.

    Measured: 6 months of lifestyle intervention

Secondary outcomes (9)

  1. Improvement of liver fibrosis

    Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs.

    Measured: 12 months of lifestyle intervention

  2. Improvement of liver steatosis

    Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan

    Measured: 6 months of lifestyle intervention

  3. Improvement of liver steatosis

    Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan

    Measured: 12 months of lifestyle intervention

  4. 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.

    Measured: 6 months of lifestyle intervention

  5. 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.

    Measured: 12 months of lifestyle intervention

  6. 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.

    Measured: 6 months of lifestyle intervention

  7. 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.

    Measured: 12 months of lifestyle intervention

  8. 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

    Measured: 6 months of lifestyle intervention

  9. 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

    Measured: 12 months of lifestyle intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2022
  2. Study start1 May 2022
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05309863
Sponsor's protocol ID
BC-05660
Status last verified
Jun 2024
First submitted
25 Mar 2022
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The plan can be obtained by contacting the researchers with a worked-out protocol for study in which these data can be used.

Publications

  • 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.

    PubMed 34871812

  • 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.

    PubMed 18563842

  • 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.

    PubMed 32623006

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Non-alcoholic Fatty Liver Disease, run by University Hospital, Ghent at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruth De Bruyne, MD, PhD (003293322966, ruth.debruyne@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of liver fibrosis (time frame: 6 months of lifestyle intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05309863, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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