BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Obesity, Morbid	Procedure: Gastric bypass; Procedure: gastric sleeve

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	30 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Changes in Bioavailability of Ethanol Following Bariatric Surgery
Actual Study Start Date :	September 2013
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Gastric bypass; patients recruited from Central Norway	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; patients recruited from Central Norway	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.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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)

Biospecimen Retention:   Samples Without DNA

blood samples

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

persons eligible for bariatric surgery in the Obesity policlinic, St Olavs Hospital, Trondheim, Norway

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Norway
Sykehuset Namsos
Namsos, Norway
Obesity policlinic of St. Olavs Hospital
Trondheim, Norway

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

Investigators

Principal Investigator:	Magnus Strommen, MSc	Norwegian University of Science and Technology

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT01840020 History of Changes
Other Study ID Numbers:	2012/1206
First Posted:	April 25, 2013
Last Update Posted:	October 11, 2017
Last Verified:	October 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Norwegian University of Science and Technology:

bariatric surgery; alcohol drinking; alcoholism; ethanol; metabolism

Additional relevant MeSH terms:

Obesity, Morbid; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight	Signs and Symptoms; Ethanol; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs