Skip to content

BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

Changes in Bioavailability of Ethanol Following Bariatric Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01840020
Enrollment
33
Registered
2013-04-25
Start date
2013-09-30
Completion date
2020-02-29
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Keywords

bariatric surgery, alcohol drinking, alcoholism, ethanol, metabolism

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.

Interventions

PROCEDUREGastric bypass

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.

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.

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in bioavailability of ethanolfrom baseline to 3 months, 1 year, and 3 yearsbioavailability tests: Plasma concentration of ethanol. Calculation: * Area under curve (AUC) * Maximum concentration(Cmax) * Time up to maximum concentration (tmax) * Oral bioavailability (AUCpo/AUCiv)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026