Impact of Weight Loss Surgery in Adolescents With NAFLD

NCT ID: NCT02952170

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-15

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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NAFLD Obesity, Adolescent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MRI for steatosis assessment

Abdominal MRI for assessment of hepatic steatosis

Group Type EXPERIMENTAL

MRI

Intervention Type OTHER

MRI to assess hepatic steatosis

Interventions

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MRI

MRI to assess hepatic steatosis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kathleen E Corey

Director - MGH Fatty Liver Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathleen Corey, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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P30DK040561

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014P001504

Identifier Type: -

Identifier Source: org_study_id

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