The aim of this study is to validate the ultrasonographic hepatorenal index in children with overweight, obesity and morbid obesity, by using MRS.
ID
Source
Brief title
Condition
- Other condition
- Hepatic and hepatobiliary disorders
Synonym
Health condition
Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ultrasonographic hepato-renal index and liver fat percentage as determined by
magnetic resonance spectroscopy.
Secondary outcome
Metabolic and anthropometric parameters, to correlate with the measured liver
parameters (for example waist-circumference, lipids, blood pressure and glucose
metabolism). The goal is to gain more insight into which children can be
identified as being at-risk for developing NAFLD based on their cardiometbolic
profile.
Background summary
Obesity is associated with a variety of co-morbidities. Children with obesity
are more likely to have risk factors associated with cardiovascular disease
(eg, hypertension, high cholesterol, and type 2 diabetes mellitus), but also
non-alcoholic fatty liver disease (NAFLD). A recent meta-analysis has shown
that the prevalence of NAFLD in obese pediatric populations is approximately
35%, compared to approximately 8% in general pediatric populations, making it a
very important health threat in these populations. The golden standard for the
diagnosis of NAFLD is liver biopsy. However, since liver biopsy is associated
with a certain risk of morbidity and mortality, this method is inappropriate
for screening large populations at-risk for developing NAFLD. Magnetic
resonance spectroscopy has demonstrated excellent correlation with liver biopsy
and the most accurate non-invasive method to measure liver fat content in
children. However, MRS is an expensive method that is not available in all
centers. A novel ultrasonographic measurement to quantitatively assess liver
steatosis is the hepatorenal index (HRI), which is calculated as the ratio of
hepatic and renal ultrasonographic brightness. Previous studies in adults have
shown a high sensitivity and specificity of the HRI, as compared to liver
biopsy as well as H-MRS. However, the measurement of the HRI has never been
validated in children. The validation of this simple, non-invasive method to
quantitatively assess fat accumulation in the liver, could improve the
screening for, and follow-up of, NAFLD in at-risk populations.
Study objective
The aim of this study is to validate the ultrasonographic hepatorenal index in
children with overweight, obesity and morbid obesity, by using MRS.
Study design
Cross-sectional study.
Study burden and risks
MRS is a safe measurement, as long as none of the before mentioned exclusion
criteria are met. Measurements performed during the study could potentially
lead to unexpected medical findings. If the subject does not want to be
informed about incidental findings, he/she cannot participate in the study.
Lying in the MR scanner can cause some discomfort, since children have to lie
still for about 45 minutes.
In adults, the HRI has shown to be an easy, reproducible method to
quantitatively measure liver fat accumulation, with a high sensitivity and
specificity (compared to liver biopsy and MRS). However, the (validity) of the
HRI has never been studied in children. Therefore, it is unknown if this method
is also reliable in pediatric populations. Also cut-off points for children are
unknown.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
· Participation in the COACH program
· Aged below 18 years
Exclusion criteria
· Steatosis on liver ultrasonography
· Elevated liver transaminase levels above two times the upper limit of normal
(>44 U/L for girls and > 52 U/L for boys)
· Implanted medical devices such as pacemakers or neurostimulators
· Metal objects in the body (for instances prosthetics, piercings, metal parts
in the eye, permanent eyeliner)
· Previous brain surgery
· Cardiac arrhythmia
· Epilepsy
· Claustrofobia
· Not wanting to be informed about accidental findings on MRS
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 | NL64534.068.18 |