NAFLDAWLSNCT02952170
Impact of Weight Loss Surgery in Adolescents With NAFLD
A study testing MRI in people with NAFLD and Obesity, Adolescent, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will assess the impact of weight loss surgery (WLS) on non-alcoholic fatty liver disease (NAFLD) in adolescents as well as the interaction between NAFLD and cardiometabolic risk. Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- NAFLD, Obesity, Adolescent
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2014to 30 Apr 2022
- Phase
- Interventional
- 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 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Obese
- Meets institutional requirements for weight loss surgery
Who cannot join
- Alcohol consumption or other causes of chronic liver disease
- Intolerance to MRI
- Weight >435 lbs
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Impact of Weight Loss Surgery in Adolescents on Fatty Liver Disease
This study will assess the impact of weight loss surgery (WLS) on non-alcoholic fatty liver disease (NAFLD) in adolescents as well as the interaction between NAFLD and cardiometabolic risk.
Read the detailed description
While the impact of WLS has been studied in adults, little is known about NAFLD in adolescents undergoing WLS. At present, only a small number of adolescents undergo WLS each year and thus this area has not been well studied. However, as the prevalence of severe obesity continues to rise the investigators anticipate that so will WLS in adolescents.
This study will establish the impact of WLS on NAFLD in adolescents. Currently, it is assumed that adolescents with NAFLD diagnosed at the time of WLS have universal resolution of their disease with appropriate weight loss, and no further evaluation is conducted. Our group has shown that up to 40% of adolescents who undergo WLS have persistently abnormal aminotransferase levels, suggesting that many may have persistent NASH and are at risk of progressive liver disease. The study will elucidate the history of NAFLD following WLS. Such data have not been previously published and will represent a significant contribution to this field.
- Conditions
- NAFLD, Obesity, Adolescent
- Being tested
- MRI
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI to assess hepatic steatosis
| Study group | Role | What they receive |
|---|---|---|
| MRI for steatosis assessment | Experimental | Abdominal MRI for assessment of hepatic steatosis Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatitis steatosis after weight loss surgery
Change in hepatitis steatosis after weight loss surgery as measured by MRS
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start15 Sep 2014
- Primary completion30 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen E Corey, Massachusetts General Hospital
- Investigators
- Kathleen Corey, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952170
- Sponsor's protocol ID
- 2014P001504
- Other IDs
- P30DK040561
- Acronym
- AWLS
- Status last verified
- Mar 2023
- First submitted
- 30 Oct 2016
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anticipate to share overall results through publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Weight Loss Surgery in Adolescents on Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02952170
- Acronym / sponsor ID
- AWLS / 2014P001504
- Conditions
- NAFLD, Obesity, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 2 Nov 2016 (estimated)
- 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.
This study will assess the impact of weight loss surgery (WLS) on non-alcoholic fatty liver disease (NAFLD) in adolescents as well as the interaction between NAFLD and cardiometabolic risk.
Detailed description
While the impact of WLS has been studied in adults, little is known about NAFLD in adolescents undergoing WLS. At present, only a small number of adolescents undergo WLS each year and thus this area has not been well studied. However, as the prevalence of severe obesity continues to rise the investigators anticipate that so will WLS in adolescents.
This study will establish the impact of WLS on NAFLD in adolescents. Currently, it is assumed that adolescents with NAFLD diagnosed at the time of WLS have universal resolution of their disease with appropriate weight loss, and no further evaluation is conducted. Our group has shown that up to 40% of adolescents who undergo WLS have persistently abnormal aminotransferase levels, suggesting that many may have persistent NASH and are at risk of progressive liver disease. The study will elucidate the history of NAFLD following WLS. Such data have not been previously published and will represent a significant contribution to this field.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI for steatosis assessment | Experimental | Other: MRIAbdominal MRI for assessment of hepatic steatosis |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Obese
- Meets institutional requirements for weight loss surgery
Key exclusion criteria (3 listed)
- Alcohol consumption or other causes of chronic liver disease
- Intolerance to MRI
- Weight >435 lbs
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 |
|---|---|---|
| MRIMRI to assess hepatic steatosis | Other | MRI for steatosis assessment |
Primary outcome
Change in hepatitis steatosis after weight loss surgery
Time frame: 7 months
Change in hepatitis steatosis after weight loss surgery as measured by MRS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Yes. Anticipate to share overall results through publication
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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.
Kathleen Corey, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with NAFLD and Obesity, Adolescent, run by Massachusetts General Hospital 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 2 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: finished, as of the sponsor's last update on 15 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in hepatitis steatosis after weight loss surgery (time frame: 7 months). 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 15 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.