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

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ClinicalTrials.gov Identifier: NCT03787108
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.

Condition or disease Intervention/treatment
Non-Alcoholic Fatty Liver Disease Other: Magnetic resonance spectroscopy measurement

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Ultrasonographic hepato-renal index [ Time Frame: Until december 2019 ]
    Ratio of hepatic and renal echogenicity

  2. Liver fat percentage [ Time Frame: Until december 2019 ]
    Liver fat percentage will be measured withmagnetic resonance spectroscopy.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Lipid spectrum [ 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

  5. Glucose metabolism [ 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

  6. Blood pressure [ 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



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive participants in the COACH program (children with overweight or obesity), that meet the inclusion criteria, will be invited to participate in this study, until the calculated sample size is reached.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Anita Vreugdenhil 0031 43 3875284 a.vreugdenhil@mumc.nl

Locations
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Netherlands
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.         
Sponsors and Collaborators
Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03787108     History of Changes
Other Study ID Numbers: NL64534.068.18
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maastricht University Medical Center:
Non-Alcoholic Fatty Liver Disease
Magnetic Resonance Spectroscopy
Ultrasonographic hepatorenal index

Additional relevant MeSH terms:
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Overweight
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Body Weight
Signs and Symptoms
Digestive System Diseases