NCT02952170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

7.3 years

First QC Date

October 30, 2016

Last Update Submit

March 13, 2023

Conditions

NAFLDObesity, Adolescent

Outcome Measures

Primary Outcomes (1)

  • Change in hepatitis steatosis after weight loss surgery

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

    7 months

Study Arms (1)

MRI for steatosis assessment

EXPERIMENTAL

Abdominal MRI for assessment of hepatic steatosis

Other: MRI

Interventions

MRIOTHER

MRI to assess hepatic steatosis

MRI for steatosis assessment

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Obese
  • Meets institutional requirements for weight loss surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseasePediatric Obesity

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kathleen Corey, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director - MGH Fatty Liver Clinic

Study Record Dates

First Submitted

October 30, 2016

First Posted

November 2, 2016

Study Start

September 15, 2014

Primary Completion

December 30, 2021

Study Completion

April 30, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Anticipate to share overall results through publication

Locations

US(1)