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CompletedNCT02952170AWLSUpdated Mar 15, 2023

Impact of Weight Loss Surgery in Adolescents With NAFLD

An interventional study of MRI in NAFLD and Obesity, Adolescent, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 15 Years to 22 Years. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Sep 2014, registered Oct 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
15 Years to 22 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • NAFLD
  • Obesity, Adolescent
03

In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

This study's enrollment of 11 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 22 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Obese
  • Meets institutional requirements for weight loss surgery

Exclusion criteria

Exclusion Criteria:

  • Alcohol consumption or other causes of chronic liver disease
  • Intolerance to MRI
  • Weight >435 lbs
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    MRI for steatosis assessment

    Abdominal MRI for assessment of hepatic steatosis

    Other: MRI

Interventions

  • OtherMRI

    MRI to assess hepatic steatosis

06

What researchers measure

Primary outcomes

  1. Change in hepatitis steatosis after weight loss surgery

    Change in hepatitis steatosis after weight loss surgery as measured by MRS

    Time frame: 7 months

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

Individual participant data

Plan to share: Yes — Anticipate to share overall results through publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02952170
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Kathleen E Corey (Director - MGH Fatty Liver Clinic, Massachusetts General Hospital) — Principal investigator
First posted
Nov 2, 2016
Start date
Sep 15, 2014
Primary completion
Dec 30, 2021
Completion
Apr 30, 2022
Last update
Mar 15, 2023

Study contacts

Kathleen Corey, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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