Non-Alcoholic Fatty Liver DiseaseNCT03787108
Measuring Fatty Liver With Ultrasound and MRS in Children With Overweight or Obesity
An observational study of Non-Alcoholic Fatty Liver Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Magnetic resonance spectroscopy measurement
- How many people
- 53 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Mar 2019to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Participation in the COACH program
- Aged below 18 years
Who cannot join
- · 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6202AZ
Anita Vreugdenhil, Dr., 0031 (0)43 387 5284
Kylie Karnebeek, Drs., 0031 (0)43 387 4402
About this study
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)
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Magnetic resonance spectroscopy measurement
- Keywords
- Non-Alcoholic Fatty Liver Disease, Magnetic Resonance Spectroscopy, Ultrasonographic hepatorenal index
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance spectroscopy measurementOther
Magnetic resonance spectroscopy measurement will be performed to measure liver fat content.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Magnetic resonance spectroscopy measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic hepato-renal index
Ratio of hepatic and renal echogenicity
Measured: Until december 2019
Liver fat percentage
Liver fat percentage will be measured withmagnetic resonance spectroscopy.
Measured: Until december 2019
Secondary outcomes (6)
BMI z-score
Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
Measured: Until december 2019
Liver enzyme levels
Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
Measured: Until december 2019
Fibrosan values
Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
Measured: Until december 2019
Lipid spectrum
Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
Measured: Until december 2019
Glucose metabolism
Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
Measured: Until december 2019
Blood pressure
Secondary outcomes will be correlated with liver fat percentage as measured with MRS and with the ultrasonographic hepato-renal index
Measured: Until december 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start31 Mar 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787108
- Sponsor's protocol ID
- NL64534.068.18
- Status last verified
- Mar 2019
- First submitted
- 30 Oct 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03787108
- Acronym / sponsor ID
- NL64534.068.18
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Non-Alcoholic Fatty Liver Disease, Magnetic Resonance Spectroscopy, Ultrasonographic hepatorenal index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 31 Mar 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with suspected NAFLD | – | Other: Magnetic resonance spectroscopy measurementChildren 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Participation in the COACH program
- Aged below 18 years
Key exclusion criteria (7 listed)
- · Implanted medical devices such as pacemakers or neurostimulators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance spectroscopy measurementMagnetic resonance spectroscopy measurement will be performed to measure liver fat content. | Other | Children with suspected NAFLD |
Primary outcome
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.
6 secondary outcomes
BMI z-score
Time frame: Until december 2019
Liver enzyme levels
Time frame: Until december 2019
Fibrosan values
Time frame: Until december 2019
Lipid spectrum
Time frame: Until december 2019
Glucose metabolism
Time frame: Until december 2019
Blood pressure
Time frame: Until december 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anita Vreugdenhil (0031 43 3875284, a.vreugdenhil@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic hepato-renal index (time frame: Until december 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.