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临床试验/NCT06064240
NCT06064240招募中不适用

Evaluation of Changes in Liver Fat Content and Exploration of Potential Effect Actors After Bariatric Surgery Based on MRI

yu li,MD1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Liver fat fraction

研究概览

简要总结

On the basis of previous research, this subject intends to evaluate the liver improvement of patients with liver disease after weight loss by MRI, and quantify it by extracting features, so as to provide a new method to judge the liver status of patients with liver disease, and to evaluate the correlation between the inflammatory status of patients and the quantitative features of MRI, and try to explain the reasons for the improvement of fatty liver status of patients with liver disease after weight loss. To provide a new theoretical basis for fatty liver and systemic inflammatory liver damage in patients with liver disease after weight loss surgery, and to link them, and try to explain the improvement of fatty liver in patients with liver disease through the reduction of systemic inflammatory level.

详细描述

This study is a prospective study to explore the improvement of fatty liver and severe state of the whole body in patients with liver disease undergoing weight-loss surgery. The research object is obese patients who underwent laparoscopic sleeve gastrectomy in our hospital. According to the standard of accepting the discharge, about 50 patients were selected and divided into groups according to preoperative, postoperative one month, postoperative three months and postoperative six months.All patients underwent routine sequence examinations using a Siemens 3.0T MRI scanner (MAGNETOM Prisma, Siemens Healthcare, Munich, Germany).This study investigates alterations in NAFLD among patients with obesity who underwent bariatric surgery using MRI-PDFF and MRS techniques. Additionally, we evaluated the factors that may influence these changes in patients after the surgical procedure.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 16 years old < age < 60 years old
  • BMI > 32kg/m2
  • No previous drinking history; weekly drinking of males < 210g and females < 140g in 12 months
  • Preoperative auxiliary examination supports the diagnosis of fatty liver, and liver MRI examination
  • Previous attempts to lose weight are ineffective
  • Complete case data.
  • Exclusion criteria:
  • Secondary obesity
  • History of drinking or excessive drinking (in the past 12 months, male's weekly alcohol intake was ≥210g, female's weekly alcohol intake was ≥ 140g)
  • Other diseases causing abnormal liver function
  • Body mass index < 28kg/m2
  • Poor compliance or self-control, unable to follow the dietary guidance after operation
  • Those who cannot complete the follow-up

排除标准

  • 未提供

结局指标

主要结局

Liver fat fraction

时间窗: before surgery、one 、three、six month after surgery

The primary outcome was a indicator for evaluating liver fat content.

aspartate aminotransferase

时间窗: before surgery、one 、three、six month after surgery

The primary outcome was a indicator for evaluating liver function.

white blood cell

时间窗: before surgery、one 、three、six month after surgery

The primary outcome was a indicator for evaluating inflammation.

alanine aminotransferase

时间窗: before surgery、one 、three、six month after surgery

The primary outcome was a indicator for evaluating liver function.

C-reactive protein

时间窗: before surgery、one 、three、six month after surgery

The primary outcome was a indicators for evaluating inflammation.

neutrophile granulocyte

时间窗: before surgery、one 、three、six month after surgery

The primary outcome was a indicator for evaluating inflammation.

次要结局

  • glucose(before surgery、one 、three、six month after surgery)
  • low-density lipoprotein(before surgery、one 、three、six month after surgery)
  • high-density lipoprotein(before surgery、one 、three、six month after surgery)

研究者

发起方
yu li,MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yu li,MD

Doctoral

The Affiliated Hospital of Qingdao University

研究点 (1)

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