BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

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.

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Key information

Conditions

Obesity, Morbid Alcohol Drinking Alcohol-Related Disorders Alcoholism Behavior Body Weight Chemically-Induced Disorders Drinking Behavior Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sykehuset Namsos, Namsos, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric bypass

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

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.

Primary outcomes

Change in bioavailability of ethanol

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

St. Olavs Hospital

Registry information

Official study title

Changes in Bioavailability of Ethanol Following Bariatric Surgery

Important dates

Study start: 2013
Primary completion: 2020
Study completion: 2020
First posted: Apr 25, 2013
Registry last updated: Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed