Measuring Fatty Liver With Ultrasound and MRS in Children With Overweight or Obesity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03787108|
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment|
|Non-Alcoholic Fatty Liver Disease||Other: Magnetic resonance spectroscopy measurement|
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 , 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.
|Study Type :||Observational|
|Estimated Enrollment :||53 participants|
|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)|
|Estimated Study Start Date :||March 31, 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Children with suspected NAFLD
Children with overweight or obesity. Both children that are and children that are not suspected of having NAFLD (based on ultrasound and laboratory findings) are included.
Other: Magnetic resonance spectroscopy measurement
Magnetic resonance spectroscopy measurement will be performed to measure liver fat content.
- Ultrasonographic hepato-renal index [ Time Frame: Until december 2019 ]Ratio of hepatic and renal echogenicity
- Liver fat percentage [ Time Frame: Until december 2019 ]Liver fat percentage will be measured withmagnetic resonance spectroscopy.
- BMI z-score [ Time Frame: Until december 2019 ]Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
- Liver enzyme levels [ Time Frame: Until december 2019 ]Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
- Fibrosan values [ Time Frame: Until december 2019 ]Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
- Lipid spectrum [ Time Frame: Until december 2019 ]
- Glucose metabolism [ Time Frame: Until december 2019 ]
- Blood pressure [ Time Frame: Until december 2019 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787108
|Contact: Anita Vreugdenhil||0031 43 email@example.com|
|Maastricht University Medical Center||Recruiting|
|Maastricht, Limburg, Netherlands, 6202AZ|
|Contact: Anita Vreugdenhil, Dr. 0031 (0)43 387 5284|
|Contact: Kylie Karnebeek, Drs. 0031 (0)43 387 4402|
|Principal Investigator: Anita Vreugdenhil, Dr.|
|Sub-Investigator: Kylie Karnebeek, Drs.|
|Sub-Investigator: Jogchum Plat, Prof. dr.|
|Sub-Investigator: Vera Schrauwen - Hinderling, Dr.|
|Sub-Investigator: Simon Robben, Prof. dr.|