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NCT02952170 Clinical Trial

Impact of Weight Loss Surgery in Adolescents With NAFLD

NAFLD Clinical Trial

— AWLS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02952170
Other study ID # 2014P001504
Secondary ID P30DK040561
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2014
Est. completion date April 30, 2022

Study information
Verified date March 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date April 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years to 22 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• MRI
MRI to assess hepatic steatosis

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in hepatitis steatosis after weight loss surgery Change in hepatitis steatosis after weight loss surgery as measured by MRS 7 months
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