BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
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ClinicalTrials.gov Identifier: NCT01840020 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 25, 2013
Last Update Posted
: October 11, 2017
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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 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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840020
Norway | |
Sykehuset Namsos | |
Namsos, Norway | |
Obesity policlinic of St. Olavs Hospital | |
Trondheim, Norway |
Principal Investigator: | Magnus Strommen, MSc | Norwegian University of Science and Technology |
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 Key Record Dates |
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 |