此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk (ADIII)

2017年5月1日 更新者:Bruno Caramelli、University of Sao Paulo

Effect of Bariatric Surgery "Digestive Adaptations III" on Clinical, Laboratory and Cardiovascular Risk Factors

Introduction- Primary prevention is the main strategy to control the global burden of cardiovascular disease. In clinical practice, food restriction represents a valuable preventive resource. However, low adhesion rates and diet abandonment are considered important obstacles in treatment. Considering the discovery of new markers and mechanisms that relate food restriction and to all other cardiovascular risk factors, it is possible and necessary to seek for efficient alternatives to increase adherence and effectiveness of the preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food restriction. The bariatric surgery have gained importance not only for its potential application in obesity treatment but also in the control of cardiovascular risk factors refractory to medical treatment. Among bariatric operations, there is a group called digestive adaptations III that has specific characteristics.This surgical intervention modifies intestinal tract by reducing gastric volume and performing an anastomosis between ileum and stomach, creating a bipartition in the gut. This structural modification promotes satiety and increased insulin sensitivity more intensely than other surgical strategies. The effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers related to the development of atherosclerosis are not yet established.

Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and laboratory parameters and cardiovascular risk factors.

Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal obesity will be included in the study. Of this group, half will be randomly selected to perform the Digestive Adaptations III surgery. All participants will undergo clinical and biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four months after surgery. On these occasions besides the lipid profile and glucose, we will determine incretin hormones, adipokines and assess the amount of epicardial fat.

研究概览

研究类型

观察性的

注册 (实际的)

30

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

      • São Paulo、巴西、05403-000
        • Heart Institute - University of São Paulo

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

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

取样方法

非概率样本

研究人群

The population will be selected in a primary care clinic.

描述

Inclusion Criteria:

  • Men.
  • Adults (raging from 18 to 65 years).
  • Ability to understand the procedure, risks and alternatives.
  • Patients with BMI > 28 Kg/m2 and < 35 Kg/m2 presenting type 2 diabetes diagnosed for more than two years and less than 10 years.
  • Glycated hemoglobin> 8% despite dietary and medical treatment that already includes the use of exogenous insulin
  • Waist circumference > 102 cm.

Exclusion Criteria:

  • Chronic diseases not related to severe obesity.
  • Pregnancy.
  • Peptide C <1.5 ng / mL or a positive anti-islet antibodies, anti-GAD or anti-ICA512.
  • Previous cancer, unless deemed cured (after 5 years of treatment, at least)
  • Acute infection or chronic relevant.
  • Alcohol addiction.
  • Tobacco use.
  • Drug addiction, except those recovered for more than three years.

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

队列和干预

团体/队列
干预/治疗
Clinical treatment
Diabetic individuals refractory to medical treatment kept under clinical treatment guidelines and lifestyle
Surgery
Diabetic individuals refractory to conservative clinical treatment subject to Digestive Adaptations III Surgery.
其他名称:
  • Sleeve gastrectomy with transit bipartition
Control
Healthy individuals (normal weight and no cardiovascular risk factors) will be used to evaluate the behavior incretin hormones in healthy individuals, serving as a benchmark to analyze the results obtained in other groups.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Improvement in Metabolic Profile
大体时间:two years
Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.
two 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

  • 学习椅:Bruno Caramelli, Ph.D.、University of Sao Paulo
  • 首席研究员:Fernanda R Azevedo, Nutr、University of Sao Paulo

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

2013年4月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2017年4月20日

研究注册日期

首次提交

2012年4月17日

首先提交符合 QC 标准的

2012年4月17日

首次发布 (估计)

2012年4月19日

研究记录更新

最后更新发布 (实际的)

2017年5月2日

上次提交的符合 QC 标准的更新

2017年5月1日

最后验证

2017年5月1日

更多信息

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.

订阅