Changes in Bioavailability of Ethanol Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in bioavailability of ethanol
研究概览
简要总结
The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass procedure, involves significant changes to the size and function of the stomach and leads to more rapid gastric emptying. Consequences will be faster absorption and higher peak concentration of ethanol after surgery than before. There are growing concerns that surgery for obesity in this way may cause alcohol abuse.
In this study the investigators compare changes in FPM of ethanol following two different bariatric surgical procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •volunteers from Central Norway
- •morbid obese BMI > 40 kg/m2)
- •morbid obese BMI > 35 kg/m2 given a obesity related disease that qualifies for bariatric surgery
排除标准
- •previous or current alcohol abuse
- •risk for alcohol harm as assessed by AUDIT
- •alcohol abstinence
- •liver disease except fatty liver, which occurs in more than 50% of those who seek bariatric surgery
- •previous colon resection
- •not/insufficiently able to informed consent
- •drugs that interact with alcohol dehydrogenase
- •drugs that slow down emptying of the stomach
- •pregnancy
结局指标
主要结局
Change in bioavailability of ethanol
时间窗: from baseline to 3 months, 1 year, and 3 years
bioavailability tests: Plasma concentration of ethanol. Calculation: * Area under curve (AUC) * Maximum concentration(Cmax) * Time up to maximum concentration (tmax) * Oral bioavailability (AUCpo/AUCiv)
次要结局
未报告次要终点