Hepatic SteatosisNCT05302258
Attenuation Imaging in Hepatic Steatosis
An observational study of Hepatic Steatosis and Obesity, Childhood, run by Hallym University Kangnam Sacred Heart Hospital.
Trial summary
For obese and normal-weight children, the investigators assess the diagnostic performance of attenuation imaging (ATI) in the detection of hepatic steatosis in children. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Steatosis, Obesity, Childhood, Ultrasonography
- What is being tested?
- Attenuation imaging in ultrasonography
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2022to 14 Dec 2022
- 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Obese and normal-weight children
Who may be able to join
- BMI of 85th percentile or less
Who cannot join
- congenital anomaly including heart, intestine, kidney
- acute hepatitis
- congenital hepatic anomaly
About this study
Official title: Noninvasive Assessment of Hepatic Steatosis by Using Attenuation Imaging in Children
For obese and normal-weight children, the investigators assess the diagnostic performance of attenuation imaging (ATI) in the detection of hepatic steatosis in children.
- Conditions
- Hepatic Steatosis, Obesity, Childhood, Ultrasonography
- Being tested
- Attenuation imaging in ultrasonography
- Medical subject headings
- Fatty Liver, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attenuation imaging in ultrasonographyDiagnostic test
Attenuation imaging in ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Obesity | BMI of 95 th percentile or more Receives: Diagnostic Test: Attenuation imaging in ultrasonography | |
| Normal weight | BMI of 85 th percentile or less Receives: Diagnostic Test: Attenuation imaging in ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of attenuation imaging
The diagnostic performance of attenuation imaging in US in the detection of hepatic steatosis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start14 Apr 2022 (estimated)
- Primary completion14 Dec 2022 (estimated)
- Study completion14 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic SteatosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302258
- Sponsor's protocol ID
- ATI
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Assessment of Hepatic Steatosis by Using Attenuation Imaging in Children
- ClinicalTrials.gov ID
- NCT05302258
- Acronym / sponsor ID
- ATI
- Conditions
- Hepatic Steatosis, Obesity, Childhood, Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 14 Apr 2022 (estimated)
- Primary completion
- 14 Dec 2022 (estimated)
- Study completion
- 14 Dec 2022 (estimated)
- First posted
- 31 Mar 2022 (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.
For obese and normal-weight children, the investigators assess the diagnostic performance of attenuation imaging (ATI) in the detection of hepatic steatosis in children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | Diagnostic Test: Attenuation imaging in ultrasonographyBMI of 95 th percentile or more |
| Normal weight | – | Diagnostic Test: Attenuation imaging in ultrasonographyBMI of 85 th percentile or less |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Obese and normal-weight children
Key inclusion criteria (1 listed)
- BMI of 85th percentile or less
Key exclusion criteria (3 listed)
- congenital anomaly including heart, intestine, kidney
- acute hepatitis
- congenital hepatic anomaly
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 |
|---|---|---|
| Attenuation imaging in ultrasonographyAttenuation imaging in ultrasonography | Diagnostic test | Normal weight, Obesity |
Primary outcome
Diagnostic performance of attenuation imaging
Time frame: through study completion, an average of 1 year
The diagnostic performance of attenuation imaging in US in the detection of hepatic steatosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Steatosis and Obesity, Childhood, run by Hallym University Kangnam Sacred Heart Hospital.
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 1 inclusion and 3 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Diagnostic performance of attenuation imaging (time frame: through study completion, an average of 1 year). 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 31 Mar 2022.