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

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ClinicalTrials.gov Identifier: NCT02952170
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kathleen E Corey, 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.

Condition or disease Intervention/treatment Phase
NAFLD Obesity, Adolescent Other: MRI Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Weight Loss Surgery in Adolescents on Fatty Liver Disease
Study Start Date : September 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI for steatosis assessment
Abdominal MRI for assessment of hepatic steatosis
Other: MRI
MRI to assess hepatic steatosis




Primary Outcome Measures :
  1. Change in hepatitis steatosis after weight loss surgery [ Time Frame: 7 months ]
    Change in hepatitis steatosis after weight loss surgery as measured by MRS



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952170


Contacts
Contact: Jenna Gustafson, MS 6177243836 LiverResearchGroup@partners.org
Contact: Kathleen Corey, MD 6177263670 LiverResearchGroup@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kathleen Corey, MD    617-726-3670    kcorey@partners.org   
Contact: Jenna Gustafson, MS    617-724-3836    jlgustafson@partners.org   
Principal Investigator: Kathleen Corey, MD         
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kathleen Corey, MD Massachusetts General Hospital

Responsible Party: Kathleen E Corey, Director - MGH Fatty Liver Clinic, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02952170     History of Changes
Other Study ID Numbers: 2014P001504
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anticipate to share overall results through publication

Additional relevant MeSH terms:
Weight Loss
Pediatric Obesity
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight