Impact of Weight Loss Surgery in Adolescents With NAFLD

Not Applicable

Completed

• Conditions: NAFLD; Obesity, Adolescent
• Interventions: Other: MRI

• Registration Number: NCT02952170
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2014-09-15
• Study First Submitted: 2016-10-30
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Primary Completion: 2021-12-30
• Study Completion: 2022-04-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI for steatosis assessment	MRI	Abdominal MRI for assessment of hepatic steatosis

Primary Outcome Measures

Name	Time	Method
Change in hepatitis steatosis after weight loss surgery	7 months	Change in hepatitis steatosis after weight loss surgery as measured by MRS

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States