BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Changes in Bioavailability of Ethanol Following Bariatric Surgery

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Procedure: Gastric bypass
* Procedure: gastric sleeve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric bypass<br>patients recruited from Central Norway | Procedure: Gastric bypass<br>* Surgical procedure in which the stomach is transected high on the body. The resulting small proximal gastric pouch is joined to any parts of the small intestine by an end-to-side surgical anastomosis.<br>|
| Gastric sleeve<br>patients recruited from Central Norway | Procedure: gastric sleeve<br>* Sleeve gastrectomy, a surgical procedure in which the stomach is reduced to about 25% of its original size, by surgical removal of a large portion of the stomach, following the major curve. The open edges are then attached together (often with surgical staples) to form a sleeve or tube with a banana shape.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bioavailability of ethanol | bioavailability tests: Plasma concentration of ethanol. Calculation: Area under curve (AUC) Maximum concentration(Cmax) Time up to maximum concentration (tmax) Oral bioavailability (AUCpo/AUCiv) | from baseline to 3 months, 1 year, and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, alcohol drinking, alcoholism, ethanol, metabolism