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Impact of Weight Loss Surgery in Adolescents With NAFLD

The Impact of Weight Loss Surgery in Adolescents on Fatty Liver Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02952170
Acronym
AWLS
Enrollment
11
Registered
2016-11-02
Start date
2014-09-15
Completion date
2022-04-30
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD, Obesity, Adolescent

Brief 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.

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.

Interventions

OTHERMRI

MRI to assess hepatic steatosis

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 22 Years
Healthy volunteers
No

Inclusion criteria

* Obese * Meets institutional requirements for weight loss surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in hepatitis steatosis after weight loss surgery7 monthsChange in hepatitis steatosis after weight loss surgery as measured by MRS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026