Steatohepatitis, NonalcoholicNCT04284371
The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Patients
An observational study of Steatohepatitis, Nonalcoholic and Hemosiderosis, run by The Geneva Foundation at 1 site in United States.
Trial summary
The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Steatohepatitis, Nonalcoholic, Hemosiderosis, Overweight Adolescents
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2016to 26 Jan 2021
- 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 10 to 17 years
- All sexes
- Child
Study population: Military dependent population male and females age 10-17 years of age
Who may be able to join
- DEERS eligible patients from the San Antonio Military Medical Center Healthy Habits clinic and pediatric endocrine, pediatric gastroenterology, adolescent, and general pediatric clinics, as well as from Wilford Hall's pediatric clinic.
- Overweight (BMI > 85% and < (Control group) Normal BMI for age and gender (BMI <85%) 95% for age and gender) or obese (BMI >/= 95% for age and gender)
- 10 - 17 years old
- Cognitively able to understand and provide written informed assent
- Written informed consent from parent or legal guardian
Who cannot join
- Current or prior history of liver disease (to include chronic hepatitis B or C, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, HIV, biliary atresia, or Caroli/choledochal disease), or other known liver disease.
- Pregnancy (self-reported or through positive beta HCG test during study)
- Current use of hepatotoxic medications associated with liver disease/failure (antifungals, methotrexate, valproic acid)
- Carrying an implantable active medical device such as a pacemaker, vagal nerve stimulator, defibrillator, or non-MRI compatible cochlear implant.
- Previous claustrophobia/anxiety with MRI scanner or developmental delays that may result in failed MRI scan (e.g.autism, anxiety disorder)
- Any alcohol use
- Predicted family PCS/loss of benefits in the next 9 months (Phase II only)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: The Prevalence of Liver Steatosis, Steatohepatitis, Fibrosis, and Hemosiderosis in Overweight and Obese US Military Dependent Pediatric Patients Using MR Elastography and Quantitative MRI
The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI
Read the detailed description
The purpose of this prospective study is to determine the prevalence NAFLD and of factors that have been associated with the diagnosis of fatty liver disease in overweight and obese children and adolescents and to determine the effectiveness of an intervention. In order to do this, we will also compare laboratory values and the ability/feasibility of new magnetic resonance technologies to first detect fatty liver disease and then to detect a difference in liver health between pediatric patients with a normal BMI and those with a BMI ≥85%. This study will consist of two phases and a reproducibility arm involving 19 voluntary subjects from Phase 1 and the control group.
Phase I:
Aim 1: To determine the prevalence and relative risk of liver fibrosis, steatosis, steatohepatitis and hemosiderosis in overweight and obese US Military dependents between ages 10 and 17 compared with normal weight controls using specialized MRI (LMS).
Aim 2: To compare results between MRI-LMS and MRE and to determine feasibility of one versus the other technology.
Aim 3: To compare liver health of controls and overweight/obese subjects to determine if there is a difference between groups.
Aim 4: To test for various biomarkers that have been shown to have an association with NASH
Phase II:
Aim 1: To evaluate the effectiveness of a nine month intervention consisting of diet and exercise education on the maintenance or reduction of liver steatosis, steatohepatitis, and fibrosis.
Aim 2: To establish whether early imaging can predict short-term clinical outcomes (eg development of pre-diabetes, worsening NAFLD, development of NASH, or a change in liver stiffness or fibrosis as measured by MRE and LMS, respectively).
Reproducibility Arm Aim 1: To evaluate the consistency of the LMS/MRE data.
- Conditions
- Steatohepatitis, Nonalcoholic, Hemosiderosis, Overweight Adolescents, Obesity, Childhood, Liver Steatosis
- Keywords
- Liver Steatosis, Overweight Adolescents
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hemosiderosis, Pediatric Obesity, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
LiverMultiScan (LMS)
LMS Imagery will be used to for observance of the prevalence of liver fibrosis, steatosis, steatohepatitis and hemosiderosis on LMS in overweight and obese US Military dependents between ages 10 and 17
Measured: 2 years
MRE
MRE imagery will be used as a comparison to the LMS imagery to help determine Liver stiffness as measured by MRE overweight and obese US Military dependents between ages 10 and 17after a 9 month intervention
Measured: 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start10 Feb 2016
- Primary completion26 Jan 2021
- Study completion26 Jan 2021
Why it stopped: lack of funding - no results to report
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatohepatitis, NonalcoholicStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Geneva Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Carlosn, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284371
- Sponsor's protocol ID
- C.2016.01
- Status last verified
- Feb 2023
- First submitted
- 25 Nov 2019
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Liver Steatosis, Steatohepatitis, Fibrosis, and Hemosiderosis in Overweight and Obese US Military Dependent Pediatric Patients Using MR Elastography and Quantitative MRI
- ClinicalTrials.gov ID
- NCT04284371
- Acronym / sponsor ID
- C.2016.01
- Conditions
- Steatohepatitis, Nonalcoholic, Hemosiderosis, Overweight Adolescents, Obesity, Childhood, Liver Steatosis
- Keywords
- Liver Steatosis, Overweight Adolescents
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of funding - no results to report
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Geneva FoundationUniversity, hospital or other
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 25 Feb 2020 (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.
The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI
Detailed description
The purpose of this prospective study is to determine the prevalence NAFLD and of factors that have been associated with the diagnosis of fatty liver disease in overweight and obese children and adolescents and to determine the effectiveness of an intervention. In order to do this, we will also compare laboratory values and the ability/feasibility of new magnetic resonance technologies to first detect fatty liver disease and then to detect a difference in liver health between pediatric patients with a normal BMI and those with a BMI ≥85%. This study will consist of two phases and a reproducibility arm involving 19 voluntary subjects from Phase 1 and the control group.
Phase I:
Aim 1: To determine the prevalence and relative risk of liver fibrosis, steatosis, steatohepatitis and hemosiderosis in overweight and obese US Military dependents between ages 10 and 17 compared with normal weight controls using specialized MRI (LMS).
Aim 2: To compare results between MRI-LMS and MRE and to determine feasibility of one versus the other technology.
Aim 3: To compare liver health of controls and overweight/obese subjects to determine if there is a difference between groups.
Aim 4: To test for various biomarkers that have been shown to have an association with NASH
Phase II:
Aim 1: To evaluate the effectiveness of a nine month intervention consisting of diet and exercise education on the maintenance or reduction of liver steatosis, steatohepatitis, and fibrosis.
Aim 2: To establish whether early imaging can predict short-term clinical outcomes (eg development of pre-diabetes, worsening NAFLD, development of NASH, or a change in liver stiffness or fibrosis as measured by MRE and LMS, respectively).
Reproducibility Arm Aim 1: To evaluate the consistency of the LMS/MRE data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Military dependent population male and females age 10-17 years of age
Key inclusion criteria (5 listed)
- DEERS eligible patients from the San Antonio Military Medical Center Healthy Habits clinic and pediatric endocrine, pediatric gastroenterology, adolescent, and general pediatric clinics, as well as from Wilford Hall's pediatric clinic.
- Overweight (BMI > 85% and < (Control group) Normal BMI for age and gender (BMI <85%) 95% for age and gender) or obese (BMI >/= 95% for age and gender)
- 10 - 17 years old
- Cognitively able to understand and provide written informed assent
- Written informed consent from parent or legal guardian
Key exclusion criteria (7 listed)
- Current or prior history of liver disease (to include chronic hepatitis B or C, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, HIV, biliary atresia, or Caroli/choledochal disease), or other known liver disease.
- Pregnancy (self-reported or through positive beta HCG test during study)
- Current use of hepatotoxic medications associated with liver disease/failure (antifungals, methotrexate, valproic acid)
- Carrying an implantable active medical device such as a pacemaker, vagal nerve stimulator, defibrillator, or non-MRI compatible cochlear implant.
- Previous claustrophobia/anxiety with MRI scanner or developmental delays that may result in failed MRI scan (e.g.autism, anxiety disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LiverMultiScan (LMS)
Time frame: 2 years
LMS Imagery will be used to for observance of the prevalence of liver fibrosis, steatosis, steatohepatitis and hemosiderosis on LMS in overweight and obese US Military dependents between ages 10 and 17
MRE
Time frame: 24
MRE imagery will be used as a comparison to the LMS imagery to help determine Liver stiffness as measured by MRE overweight and obese US Military dependents between ages 10 and 17after a 9 month intervention
Results and safety
The study was stopped early (reason given: lack of funding - no results to report). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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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.
Christian Carlosn, MD principal investigator
Brooke Army Medical Center
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 Steatohepatitis, Nonalcoholic and Hemosiderosis, run by The Geneva Foundation at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 24 Feb 2023. 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 United States. 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?
The study was stopped early (reason given: lack of funding - no results to report). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LiverMultiScan (LMS) (time frame: 2 years). 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 24 Feb 2023.