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BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01840020
First Posted: April 25, 2013
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose

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 Intervention
Obesity, Morbid Procedure: Gastric bypass Procedure: gastric sleeve

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in Bioavailability of Ethanol Following Bariatric Surgery

Resource links provided by NLM:

MedlinePlus related topics: Weight Loss Surgery
U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01840020     History of Changes
Other Study ID Numbers: 2012/1206
First Submitted: April 15, 2013
First Posted: April 25, 2013
Last Update Posted: October 6, 2016
Last Verified: October 2016

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


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