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Impact of Weight Loss Surgery in Adolescents With NAFLD (AWLS)

Primary Purpose

NAFLD, Obesity, Adolescent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for NAFLD

Eligibility Criteria

15 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI for steatosis assessment

Arm Description

Abdominal MRI for assessment of hepatic steatosis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 30, 2016
Last Updated
March 13, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02952170
Brief Title
Impact of Weight Loss Surgery in Adolescents With NAFLD
Acronym
AWLS
Official Title
The Impact of Weight Loss Surgery in Adolescents on Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2014 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Obesity, Adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI for steatosis assessment
Arm Type
Experimental
Arm Description
Abdominal MRI for assessment of hepatic steatosis
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
MRI to assess hepatic steatosis
Primary Outcome Measure Information:
Title
Change in hepatitis steatosis after weight loss surgery
Description
Change in hepatitis steatosis after weight loss surgery as measured by MRS
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Corey, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anticipate to share overall results through publication

Learn more about this trial

Impact of Weight Loss Surgery in Adolescents With NAFLD

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