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临床试验/NCT02952170
NCT02952170已完成不适用

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

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2014年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Change in hepatitis steatosis after weight loss surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Meets institutional requirements for weight loss surgery

排除标准

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

结局指标

主要结局

Change in hepatitis steatosis after weight loss surgery

时间窗: 7 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen E Corey

Director - MGH Fatty Liver Clinic

Massachusetts General Hospital

研究点 (2)

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