Measuring Fatty Liver With Ultrasound and MRS in Children With Overweight or Obesity

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Measuring Fatty Liver With Ultrasound and MRS in Children With Overweight or Obesity (Dutch Title: Het Meten Van Leververvetting Met Echo en MRS in Kinderen Met Overgewicht of Obesitas)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787108
• Other study ID #: NL64534.068.18
• Status: Recruiting
• Start date: March 31, 2019
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Maastricht University Medical Center
• Contact: Anita Vreugdenhil
• Phone: 0031 43 3875284
• Email: a.vreugdenhil[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obesity is associated with a variety of comorbidities, amongst which non-alcoholic fatty liver disease (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese pediatric populations is around 35%, compared to approximately 8% in general pediatric populations, making it a very important health threat in these populations. The golden standard for 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 is the most accuratete non-invasive method to measure liver fat content in children. However, MRS is expensive and not available in all centres. A novel ultrasonographic measurement to quantitatively assess liver steatosis is the hepatorenal index (HRI). Previous studies have shown high sensitivity and specificity of the HRI, as compared to MRS and liver biopsy. However, this measurement has never been validated in children. In this study, the HRI will be compared to MRS in children with obesity, to validate the HRI and to determine cut-off points.

Description:

Rationale: 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 [6], 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.

Objective: The aim of this study is to validate the ultrasonographic hepatorenal index in children with overweight, obesity and morbid obesity, by using MRS, and to determine cut-off points for the HRI according to liver fat percentages measured with MRS.

Study design: cross-sectional study

Study population: Overweight and obese children from the Centre for Overweight Adolescent and Childrens Healthcare (COACH) program.

Main study parameters/endpoints: Ultrasonographic hepato-renal index and liver fat percentage as determined by magnetic resonance spectroscopy.

Secondary study parameters/endpoints: correlate liver fat percentage as measured with MRS, and HRI, with anthropometric, metabolic and cardiovascular parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Participation in the COACH program

• Aged below 18 years

Exclusion Criteria:

• · 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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Overweight

Intervention

Other:
• Magnetic resonance spectroscopy measurement
Magnetic resonance spectroscopy measurement will be performed to measure liver fat content.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasonographic hepato-renal index	Ratio of hepatic and renal echogenicity	Until december 2019
Primary	Liver fat percentage	Liver fat percentage will be measured withmagnetic resonance spectroscopy.	Until december 2019
Secondary	BMI z-score	Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index	Until december 2019
Secondary	Liver enzyme levels	Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index	Until december 2019
Secondary	Fibrosan values	Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index	Until december 2019
Secondary	Lipid spectrum	Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index	Until december 2019
Secondary	Glucose metabolism	Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index	Until december 2019
Secondary	Blood pressure	Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index	Until december 2019