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临床试验/NCT05505773
NCT05505773已完成不适用

Prospective Clinical Study to Evaluate the Metabolism Using the Breezing Device in the Preoperative and Postoperative Periods of Gastric Bypass in Patients With Type II Diabetes.

Kaiser Clinic and Hospital0 个研究点目标入组 200 人开始时间: 2017年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
主要终点
To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

研究概览

简要总结

To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

详细描述

Objective of the research:

Primary To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

Secondary

  • To measure the indirect metabolic rate by quantifying O2 gas consumption (g) and CO2 gas release (g);
  • To analyze the 'population impact', that is, to measure using statistical tools how many cases of metabolic maladjustment could be prevented if the diabetes risk factor were to be eliminated;
  • To correlate, by means of a regression test, if there is any dependence between the metabolic rate and the diabetes risk factor;
  • To validate the accuracy of the Breezing® device.

Evaluation of the risks and benefits Risks As the patient only needs to blow on the Breezing® device using a small straw (blower), the direct risks are minimal, perhaps contamination due to failure to exchange the blower. Thus, the risks are indirect and are more associated to the malfunctioning of the device.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • over 18 years -

排除标准

  • 未提供

结局指标

主要结局

To evaluate the systemic metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

时间窗: 2 years

metabolic rate of diabetic patients before and after bariatric gastric bypass surgery using the Breezing® device.

次要结局

未报告次要终点

研究者

发起方
Kaiser Clinic and Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiz Gustavo de Quadros, MD

Prospective Clinical Study to Evaluate the Metabolism Using the Breezing Device in the Preoperative and Postoperative Periods of Gastric Bypass in Patients With Type II Diabetes.

Kaiser Clinic and Hospital

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