NCT03787108

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 31, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

October 30, 2018

Last Update Submit

March 20, 2019

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Non-Alcoholic Fatty Liver DiseaseMagnetic Resonance SpectroscopyUltrasonographic hepatorenal index

Outcome Measures

Primary Outcomes (2)

  • Ultrasonographic hepato-renal index

    Ratio of hepatic and renal echogenicity

    Until december 2019

  • Liver fat percentage

    Liver fat percentage will be measured withmagnetic resonance spectroscopy.

    Until december 2019

Secondary Outcomes (6)

  • BMI z-score

    Until december 2019

  • Liver enzyme levels

    Until december 2019

  • Fibrosan values

    Until december 2019

  • Lipid spectrum

    Until december 2019

  • Glucose metabolism

    Until december 2019

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Magnetic resonance spectroscopy measurementOTHER

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

Children with suspected NAFLD

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Participation in the COACH program
  • Aged below 18 years

You may not qualify if:

  • · 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Anita Vreugdenhil

CONTACT

0031 43 3875284a.vreugdenhil@mumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

December 26, 2018

Study Start

March 31, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations

NL(1)