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.
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
- 否
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
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
