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Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population

2016年4月25日 更新者:Guang Ning、Shanghai Jiao Tong University School of Medicine
This is a long-term follow-up and interventional study in individuals who have been diagnosed with moderate to severe obesity with or without diabetes. The purpose of this study is to determine the effects of sleeve gastrectomy on weight and blood sugar control and underlying mechanisms by metabolomics, metagenomics, functional magnetic resonance imaging (fMRI) ,adipose tissue expression chip and etc.

研究概览

地位

未知

条件

详细说明

Prevalence of obesity has been increasing rapidly worldwide. Overweight and obesity prevalence surged to 35.1% according to China Noncommunicable Disease Surveillance 2010. An estimated 44% of the burden for diabetes has been attributed to these weight problems, as well as 23% and 7-41% of the burdens for ischaemic heart disease and specific cancers. So now, obesity is a very serious disease, and it is not easy to lose weight or maintain proper weight.

With the failure of non-surgical strategies, bariatric surgery has emerged as the most effective therapeutic option for the treatment of severe obesity. From the beginning, there are a lot of types of operation which have been created and then been abandoned. Now, the most common is Roux-en-Y gastric bypass, sleeve gastrectomy (SG), gastric banding, and biliopancreatic diversion. In recent years, the international status of SG surgery gradually went up. Since 2013, SG has been recommended as the preferred option of bariatric surgery by the American Weight Loss Society. However, the underlying mechanism of SG procedure is not fully clear.

In fact, clinical and translational studies over the last decade have shown that a number of gastrointestinal mechanisms, including changes in gut hormones, neural signalling, intestinal flora, bile acid and lipid metabolism can play a significant role in the effects of this procedure on energy homeostasis. This is a long-term follow-up and interventional study in individuals who have been diagnosed with moderate to severe obesity with or without diabetes. The purpose of this study is to determine the effects of SG on weight and blood sugar control and underlying mechanisms by metabolomics, metagenomics, functional magnetic resonance imaging (fMRI) ,adipose tissue expression chip and etc.

研究类型

介入性

注册 (预期的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Shanghai
      • Shanghai、Shanghai、中国、200025
        • 招聘中
        • Shanghai Jiao Tong University School of Medicine
        • 首席研究员:
          • Guang Ning, MD,PhD
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 60年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • BMI≥35kg/m2 with or without obesity complications
  • BMI≥32kg/m2 with type 2 diabetes, high blood pressure, severe OSAHS, atherosclerotic plaque formation or other obesity complications
  • Type 2 diabetes duration of ≤ 15 years, half of the lower limit of normal islet reserve function or more, C peptide ≥2.

Exclusion Criteria:

  • had an operation for losing weight before
  • serious hepatic or renal dysfunction
  • mentally ill,serious tristimania,personality disturbance,disgnosia
  • drug abuse or alcool abuse
  • ulcer or tumor history or other high risks for surgery or serious gastrointestinal disease
  • can not be follow-up,refuse to change the life-style
  • type 1 diabetes mellitus
  • self-care disable or no familial care
  • obesity caused by drugs
  • secondary obesity, such as monogenic obesity, obesity-related genetic syndrome, cushing syndrome and etc.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Bariatric Surgery
Sleeve Gastrectomy
After complete exams such as EKG,UCG,spirometry and other basic exams,estimate the condition of patient whether he(she) can tolerate a surgical operation.Then we operate the"Sleeve gastrectomy laparoscopically" by a group of experienced surgeons.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Excess Weight Loss
大体时间:up to 10 years
up to 10 years

次要结果测量

结果测量
大体时间
Remission rate of type 2 diabetes mellitus or control of glycemia
大体时间:up to 10 years
up to 10 years
Waist circumference
大体时间:up to 10 years
up to 10 years
Hip circumference
大体时间:up to 10 years
up to 10 years
Fat percent determined by Inbody 720
大体时间:up to 10 years
up to 10 years
Assessment of insulin resistance
大体时间:up to 10 years
up to 10 years
Abdominal fat deposition
大体时间:up to 10 years
up to 10 years
Apnea hypopnea index by polysomnography
大体时间:up to 10 years
up to 10 years
Appetite assessed by Three-factor eating questionnaire (TFEQ)
大体时间:up to 10 years
up to 10 years
Gut microbiome
大体时间:up to 10 years
up to 10 years
Concentration of blood metabolites
大体时间:up to 10 years
up to 10 years
Appetite signal in brain determined by fMRI
大体时间:up to 10 years
up to 10 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Guang Ning, MD,PHD、Shanghai Jiao Tong University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年2月1日

初级完成 (预期的)

2018年12月1日

研究完成 (预期的)

2018年12月1日

研究注册日期

首次提交

2015年12月30日

首先提交符合 QC 标准的

2016年1月9日

首次发布 (估计)

2016年1月12日

研究记录更新

最后更新发布 (估计)

2016年4月26日

上次提交的符合 QC 标准的更新

2016年4月25日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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