BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

Completed

• Conditions: Obesity, Morbid
• Interventions: Procedure: Gastric bypass; Procedure: gastric sleeve

• Registration Number: NCT01840020
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Study Start: 2013-09
• Status Verified: 2020-02
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastric bypass	Gastric bypass	patients recruited from Central Norway
Gastric sleeve	gastric sleeve	patients recruited from Central Norway

Primary Outcome Measures

Name	Time	Method
Change in bioavailability of ethanol	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)

Trial Locations

Locations (2)

Sykehuset Namsos; 🇳🇴 Namsos, Norway

Obesity policlinic of St. Olavs Hospital; 🇳🇴 Trondheim, Norway