Overview

This trial is active, not recruiting.

Condition obesity, morbid
Treatments gastric bypass, gastric sleeve
Sponsor Norwegian University of Science and Technology
Collaborator St. Olavs Hospital
Start date September 2013
End date December 2018
Trial size 30 participants
Trial identifier NCT01840020, 2012/1206

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
patients recruited from Central Norway
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.
patients recruited from Central Norway
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.

Primary Outcomes

Measure
Change in bioavailability of ethanol
time frame: from baseline to 3 months, 1 year, and 3 years

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Changes in Bioavailability of Ethanol Following Bariatric Surgery
Principal investigator Magnus Strommen, MSc
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.