BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

NCT ID: NCT01840020

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2020-02-29

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.

Conditions

Obesity, Morbid

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Gastric bypass

patients recruited from Central Norway

Gastric bypass

Intervention Type: PROCEDURE

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.

Gastric sleeve

patients recruited from Central Norway

gastric sleeve

Intervention Type: PROCEDURE

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.

Interventions

Gastric 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.

Intervention Type: PROCEDURE

gastric sleeve

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magnus Strommen, MSc

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Sykehuset Namsos

Namsos, , Norway

Obesity policlinic of St. Olavs Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

2012/1206

Identifier Type: -

Identifier Source: org_study_id