To determine the 1 year sustainability of the effects of a lifestyle intervention on NAFLD in severely obese children and determine the relation between long term changes in liver steatosis and other clinical and biochemical parameters. Finally, to…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in percentage of liver steatosis between end of treatment in previous
study and one year later.
Secondary outcome
Correlation between change in liver steatosis and changes in a panel of risk
factors.
Change in status of carotid atherosclerosis between start of treatment in
previous study and one year later and correlation with change in the perentage
of liver steatosis.
Background summary
In February 2008, a study protocol titled *Non-alcoholic fatty liver disease in
obese children: measuring liver steatosis by MR Spectroscopy* (MEC number
07/141) was started. In that study, 50 children with non-alcoholic fatty liver
disease (NAFLD) are being identified from a cohort of severely obese children
and the effects of 6 months of lifestyle intervention on NAFLD are evaluated.
Proton magnetic resonance spectroscopy (1H-MRS) is used in that study to
non-invasively and accurately measure liver steatosis.
Even more important than short term effects is the sustainability of the
effects of lifestyle interventions on NAFLD. In the presently proposed
follow-up study protocol, the sustainability of the effects of lifestyle
interventions on NAFLD are investigated. Only one paediatric study into the
long term efficacy has been published. In that study, ultrasonography and serum
transaminases are used which are inaccurate diagnostic tools to determine
NAFLD.
Study objective
To determine the 1 year sustainability of the effects of a lifestyle
intervention on NAFLD in severely obese children and determine the relation
between long term changes in liver steatosis and other clinical and biochemical
parameters. Finally, to determine whether long term changes in liver steatosis
are related to changes in signs of atherosclerosis.
Study design
In a previously identified cohort of obese children with NAFLD, we will measure
liver steatosis using 1H-MRS, measure body fat distribution using conventional
MR imaging, perform ultrasound of the carotid arteries for signs of
arthrosclerosis and collect clinical and biochemical data one year after these
children participated in a lifestyle intervention program.
Study burden and risks
Participants in this study have all been identified as suffering from NAFLD in
the previous study. It is standard clinical care that NAFLD is followed up by
imaging and blood sampling every 6-12 months in order to identify deterioration
of liver function. In the previous study permission was asked to contact
patients for future studies. When a patient is included in the study all
examinations will be performed during one visit to the AMC hospital. 1H-MRS and
MR body fat distribution imaging together is a non-invasive, non-ionizing 30
minute examination in the MRI scanner. Ultrasound of carotid arteries takes
about 15-20 minutes and is safe, non-invasive, and subject friendly. Blood
sampling will be performed after an overnight fast. History taking and physical
examination will take place in the paediatric outpatient clinic of the AMC
hospital and will take 15 minutes.
meibergdreef 9
1100 AZ amsterdam
NL
meibergdreef 9
1100 AZ amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Presence of NAFLD determined by 1H-MRS before treatment
- Completion of at least 2 months of life style intervention at Heideheuvel institute
- Liver fat determined by 1H-MRS after treatment
Exclusion criteria
Other liver disease
Significant alcohol consumption
Use of steatogenic drugs
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL29337.018.09 |