BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

Obesity, Morbid Clinical Trial

Official title:

Changes in Bioavailability of Ethanol Following Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840020
• Other study ID #: 2012/1206
• Status: Completed
• Start date: September 2013
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Norway	Sykehuset Namsos	Namsos
Norway	Obesity policlinic of St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bioavailability of ethanol	bioavailability tests: Plasma concentration of ethanol. Calculation: Area under curve (AUC); Maximum concentration(Cmax); Time up to maximum concentration (tmax); Oral bioavailability (AUCpo/AUCiv)	from baseline to 3 months, 1 year, and 3 years